440 Corporate Governance jobs in Kenya
Senior Legal Counsel, Corporate Governance
40100 Kitale, Rift Valley
KES900000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client is seeking a highly motivated and experienced Senior Legal Counsel specializing in Corporate Governance to join their dynamic, fully remote legal team. This pivotal role requires a deep understanding of corporate law, regulatory compliance, and best practices in corporate governance. As a remote-first organization, we foster a collaborative environment where legal professionals can thrive regardless of their physical location. You will be instrumental in advising the company on a wide range of legal matters, ensuring adherence to all applicable laws and regulations. Your responsibilities will include drafting and reviewing complex legal documents, managing litigation, providing strategic legal advice to senior management, and developing and implementing internal legal policies and procedures. A significant part of your role will involve ensuring the company's compliance with all corporate governance requirements, including board resolutions, shareholder agreements, and statutory filings. You will also play a key role in risk management, identifying and mitigating potential legal and compliance risks across the organization. The ideal candidate will possess exceptional analytical skills, a meticulous attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Strong communication and interpersonal skills are essential for building effective relationships with internal stakeholders and external legal counsel. This is an excellent opportunity for a seasoned legal professional looking to make a significant impact in a forward-thinking, fully remote company. The role is based in Kenya, but with a strong emphasis on remote work, offering flexibility and work-life balance. Key responsibilities include:
- Providing expert legal advice on corporate law, securities law, and general business matters.
- Overseeing the company's compliance with corporate governance best practices and regulatory requirements.
- Drafting, reviewing, and negotiating a variety of legal agreements, contracts, and other corporate documents.
- Managing and advising on litigation and dispute resolution matters.
- Developing and implementing internal policies and procedures to ensure legal and regulatory compliance.
- Conducting legal research and analysis on complex legal issues.
- Advising on mergers, acquisitions, and other corporate transactions.
- Ensuring compliance with data privacy regulations and other applicable laws.
- Collaborating with cross-functional teams to provide legal support and guidance.
- Mentoring junior legal staff and contributing to the development of the legal department.
- A Bachelor of Laws (LLB) degree from a reputable university.
- A Post Graduate Diploma in Legal Practice from the Kenya School of Law.
- Admission as an Advocate of the High Court of Kenya.
- A minimum of 8 years of post-qualification experience in corporate law, with a significant focus on corporate governance.
- Proven experience advising public or private companies on compliance and governance matters.
- In-depth knowledge of Kenyan corporate law and regulatory frameworks.
- Excellent legal drafting, negotiation, and analytical skills.
- Strong understanding of contract law and commercial transactions.
- Demonstrated ability to manage a diverse workload and meet tight deadlines.
- Exceptional written and verbal communication skills.
- A proactive and solutions-oriented approach to legal challenges.
- Proficiency in legal research tools and technologies.
This advertiser has chosen not to accept applicants from your region.
0
Senior Pharmaceutical Regulatory Affairs Specialist
20100 Mwembe
KES260000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a global pharmaceutical leader committed to innovation and patient well-being, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to spearhead their remote regulatory compliance initiatives. This is a fully remote position, allowing you to influence regulatory strategies from anywhere.
The Senior Regulatory Affairs Specialist will be responsible for developing and executing global regulatory strategies for pharmaceutical product registration and lifecycle management. You will ensure compliance with diverse international regulatory requirements, manage submissions, and provide expert guidance to internal teams. Your role is pivotal in bringing life-saving medicines to market.
Key Responsibilities:
Qualifications:
This is a critical role within the pharmaceutical industry, offering a chance to make a profound impact on global health by ensuring timely access to essential medicines. You will be instrumental in navigating complex regulatory pathways, supporting regulatory efforts relevant to markets including Nakuru, Nakuru, KE .
The Senior Regulatory Affairs Specialist will be responsible for developing and executing global regulatory strategies for pharmaceutical product registration and lifecycle management. You will ensure compliance with diverse international regulatory requirements, manage submissions, and provide expert guidance to internal teams. Your role is pivotal in bringing life-saving medicines to market.
Key Responsibilities:
- Develop and implement global regulatory strategies for new drug applications (NDAs) and variations.
- Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities worldwide.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, local authorities) to facilitate approvals and address inquiries.
- Monitor and interpret evolving regulatory landscapes, guidelines, and policies.
- Provide regulatory guidance and support to product development, manufacturing, and marketing teams.
- Manage post-approval activities, including supplements, annual reports, and labeling updates.
- Conduct regulatory intelligence activities to identify opportunities and potential risks.
- Ensure compliance with all applicable pharmaceutical regulations and guidelines.
- Manage regulatory documentation and databases.
- Mentor junior regulatory affairs professionals in a remote setting.
Qualifications:
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements and submission processes in major markets (e.g., US, EU, Canada, Japan).
- Proven experience in preparing and submitting successful marketing authorization applications.
- Strong understanding of drug development, manufacturing (GMP), and quality assurance principles.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, including strong negotiation abilities.
- Ability to manage complex projects and work independently in a remote environment.
- Experience with electronic submission gateways and regulatory information management systems.
- Demonstrated ability to collaborate effectively with cross-functional teams.
This is a critical role within the pharmaceutical industry, offering a chance to make a profound impact on global health by ensuring timely access to essential medicines. You will be instrumental in navigating complex regulatory pathways, supporting regulatory efforts relevant to markets including Nakuru, Nakuru, KE .
This advertiser has chosen not to accept applicants from your region.
1
Senior Regulatory Affairs Specialist - Pharmaceuticals
80100 Nairobi, Nairobi
KES270000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Specialist to join their fully remote regulatory affairs department. This role is critical in ensuring that all company products comply with national and international regulatory requirements throughout their lifecycle. The ideal candidate will possess a deep understanding of pharmaceutical regulations, submission processes, and health authority interactions. You will be responsible for preparing, reviewing, and submitting regulatory filings, managing post-approval changes, and providing regulatory guidance to internal teams.
Key responsibilities include:
Qualifications:
Key responsibilities include:
- Preparing and submitting regulatory dossiers (e.g., CTD, ANDA, NDA) for new drug applications and variations in various markets.
- Reviewing and approving labeling, promotional materials, and advertising to ensure regulatory compliance.
- Managing post-approval regulatory activities, including amendments, supplements, and annual reports.
- Interacting with regulatory health authorities (e.g., KEBS, FDA, EMA) for submissions and inquiries.
- Providing regulatory guidance and strategy to cross-functional teams, including R&D, clinical, manufacturing, and quality assurance.
- Staying updated on current and emerging regulatory trends, guidelines, and legislation affecting the pharmaceutical industry.
- Conducting regulatory intelligence assessments and contributing to the development of regulatory strategies.
- Maintaining regulatory compliance databases and ensuring accurate record-keeping.
- Leading and participating in regulatory inspections and audits.
- Assisting in the development and implementation of regulatory affairs policies and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree (M.S., Ph.D., Pharm.D.) is a plus.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience with regulatory submissions and interactions with health authorities.
- Strong knowledge of GMP, GCP, and GLP principles.
- Familiarity with global regulatory requirements and submission formats (e.g., ICH guidelines, CTD).
- Excellent written and verbal communication skills, with meticulous attention to detail.
- Strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a fully remote, international team environment.
- Proficiency in Microsoft Office Suite.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmaceutical Regulatory Affairs Specialist
90100 Mumbuni
KES170000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking a meticulous and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This role is critical in ensuring that all company products comply with relevant national and international pharmaceutical regulations. You will be responsible for preparing, submitting, and managing regulatory filings, liaising with health authorities, and providing strategic guidance on regulatory requirements throughout the product lifecycle. Your expertise will span across drug development, manufacturing, and marketing. The ideal candidate will possess a deep understanding of regulatory frameworks, excellent attention to detail, and strong project management skills. This position requires a proactive approach to navigating complex regulatory landscapes and the ability to collaborate effectively with cross-functional teams in a remote setting.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory dossiers for drug product registrations and variations.
- Ensure compliance with relevant regulatory guidelines (e.g., FDA, EMA, WHO).
- Liaise with health authorities and regulatory agencies on behalf of the company.
- Develop and maintain regulatory strategies for product development and lifecycle management.
- Monitor changes in regulatory legislation and provide guidance to internal teams.
- Review marketing materials and product labeling for regulatory compliance.
- Manage post-approval regulatory commitments and submissions.
- Collaborate with R&D, clinical, manufacturing, and quality assurance teams.
- Conduct regulatory intelligence activities to stay abreast of industry changes.
- Advise on regulatory requirements for new product development projects.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of pharmaceutical regulations and guidelines.
- Experience in preparing Common Technical Document (CTD) modules.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information management systems.
- Ability to manage multiple projects and meet strict deadlines in a remote environment.
- Strong analytical and problem-solving skills.
This advertiser has chosen not to accept applicants from your region.
3
Remote Pharmaceutical Regulatory Affairs Specialist
10100 Embu, Eastern
KES100000 month
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking an experienced and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to join their team. This position is fully remote, allowing you to contribute to global drug development and market access from your home office. You will be responsible for ensuring that the company's products comply with all relevant national and international regulations, guiding product development through the regulatory lifecycle. Your key duties will include preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA, MAA), responding to regulatory authority queries, and staying updated on evolving regulatory landscapes and guidelines. You will liaise with internal departments (R&D, Clinical, Manufacturing) and external partners to gather necessary information and ensure a coordinated approach to regulatory submissions. A strong understanding of pharmaceutical product development, clinical trial processes, and global regulatory requirements is crucial. Experience with specific therapeutic areas or product types (e.g., biologics, generics, medical devices) is a plus. The ideal candidate will possess excellent written and verbal communication skills, meticulous attention to detail, and the ability to manage multiple projects under tight deadlines in a remote, fast-paced environment. Strong analytical and problem-solving skills, coupled with a proactive approach to regulatory challenges, are essential. This is an excellent opportunity to make a significant impact on bringing life-saving and life-improving medicines to patients worldwide.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory submissions (e.g., IND, NDA, MAA).
- Ensure compliance with global pharmaceutical regulations and guidelines.
- Liaise with health authorities for product registration and approval processes.
- Provide regulatory guidance throughout the product development lifecycle.
- Review and approve labeling, advertising, and promotional materials.
- Monitor regulatory changes and assess their impact on company products.
- Collaborate with cross-functional teams (R&D, Clinical, Quality, Manufacturing).
- Manage post-approval regulatory activities, including variations and renewals.
- Maintain regulatory databases and documentation.
- Conduct regulatory intelligence gathering and analysis.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 3 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers for major markets (e.g., US, EU).
- Thorough understanding of ICH guidelines and regional regulatory requirements.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to manage multiple projects and meet deadlines in a remote setting.
- Proficiency in regulatory information management systems.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Regulatory Affairs Specialist
00100 Abothuguchi West
KES370000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client is a leading pharmaceutical company seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in a fully remote capacity. This vital role will ensure compliance with all relevant national and international pharmaceutical regulations. You will be responsible for preparing, submitting, and maintaining regulatory filings, including New Drug Applications (NDAs), Investigational New Drug (IND) applications, and variations. Key responsibilities include staying abreast of evolving regulatory landscapes, providing regulatory guidance to product development teams, and conducting regulatory assessments for new product development and lifecycle management. You will also manage communications with regulatory authorities, address inquiries, and ensure all documentation meets regulatory standards. Strong understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines is essential. The ideal candidate will have a proven track record of successfully navigating complex regulatory pathways and achieving timely approvals for pharmaceutical products. Excellent analytical, writing, and communication skills are required, along with meticulous attention to detail. This is a remote-first position, requiring a self-disciplined individual with strong organizational abilities and the capacity to manage multiple complex projects independently. You will collaborate closely with R&D, quality assurance, and commercial teams to ensure regulatory compliance. A Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related scientific discipline is required; a Ph.D. or relevant regulatory affairs certification (e.g., RAC) is highly desirable. You will play a crucial role in bringing innovative therapies to market.
Responsibilities:
Qualifications:
Responsibilities:
- Prepare and submit regulatory documentation for drug approvals.
- Ensure compliance with all applicable pharmaceutical regulations and guidelines.
- Liaise with regulatory agencies and respond to inquiries.
- Provide regulatory strategic guidance to product development teams.
- Conduct regulatory assessments and due diligence.
- Manage post-approval regulatory activities and lifecycle management.
- Review and approve labeling and promotional materials for regulatory compliance.
- Contribute to the development of regulatory strategies for new products.
Qualifications:
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory filings (e.g., NDAs, INDs).
- In-depth knowledge of global pharmaceutical regulations and guidelines.
- Excellent scientific writing and communication skills.
- Strong analytical and problem-solving abilities.
- Ability to manage complex projects independently in a remote setting.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
- Regulatory affairs certification (e.g., RAC) is a significant plus.
This advertiser has chosen not to accept applicants from your region.
5
Remote Pharmaceutical Regulatory Affairs Specialist
00100 Makongeni
KES115000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client , a respected pharmaceutical company, is seeking a diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their fully remote global team. This critical role ensures that all company products comply with the stringent regulatory requirements of pharmaceutical markets worldwide. If you have a strong background in regulatory affairs and are adept at navigating complex compliance landscapes from a remote setting, this opportunity is for you.
Responsibilities:
Qualifications:
This remote role offers the flexibility to contribute to critical pharmaceutical projects from anywhere, impacting global health outcomes. Join a dedicated team committed to bringing life-saving medicines to patients worldwide.
Responsibilities:
- Prepare, review, and submit regulatory dossiers and applications (e.g., CTD, ANDA, NDA) to health authorities globally.
- Interpret and apply relevant regulations, guidelines, and standards (FDA, EMA, WHO, etc.) to company products and processes.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise with health authorities and respond to their queries during the review process.
- Assess the regulatory impact of product changes, manufacturing processes, and labeling updates.
- Develop and maintain regulatory strategies for product development and lifecycle management.
- Collaborate with R&D, manufacturing, quality assurance, and marketing departments to ensure regulatory compliance.
- Monitor changes in the regulatory landscape and advise the company on necessary adjustments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) as applicable.
- Review promotional materials and marketing claims for regulatory compliance.
- Maintain regulatory documentation and databases.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 4 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of international regulatory requirements and submission processes.
- Experience in preparing and filing regulatory submissions for various product types (e.g., new chemical entities, generics, biologics).
- Strong understanding of drug development, manufacturing, and quality assurance principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Proficiency in using regulatory information management systems (RIMS) is a plus.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote environment.
- Strong interpersonal skills and the ability to collaborate effectively with diverse teams.
- Familiarity with pharmacovigilance requirements and adverse event reporting.
- Commitment to maintaining the highest standards of regulatory compliance.
This remote role offers the flexibility to contribute to critical pharmaceutical projects from anywhere, impacting global health outcomes. Join a dedicated team committed to bringing life-saving medicines to patients worldwide.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Corporate governance Jobs in Kenya !
6
Senior Pharmaceutical Regulatory Affairs Specialist
30200 Kitale, Rift Valley
KES95000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading global pharmaceutical company focused on innovative drug development, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote regulatory team. This critical position offers the chance to contribute your expertise in navigating complex regulatory landscapes and ensuring product compliance from anywhere in the world. You will play a vital role in guiding the company through the regulatory submission and approval processes for new pharmaceutical products.
In this role, you will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities worldwide, ensuring adherence to all applicable guidelines and regulations. You will monitor regulatory changes and provide strategic advice to product development teams regarding regulatory requirements. Key responsibilities include managing post-approval regulatory activities, such as variations, renewals, and labeling updates. You will also collaborate with R&D, clinical, manufacturing, and marketing departments to ensure alignment on regulatory strategies and timelines.
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field, with advanced degrees or certifications in Regulatory Affairs being highly desirable. A minimum of 8 years of experience in pharmaceutical regulatory affairs is required, with a strong understanding of global regulatory submission processes (e.g., CTD, eCTD) and familiarity with major health authority requirements (e.g., FDA, EMA, PMDA). Excellent analytical, communication, and project management skills are essential, along with meticulous attention to detail. The ability to work independently and collaboratively within a remote team environment is crucial. This is an exceptional opportunity to make a significant impact on bringing life-saving medicines to patients worldwide, in a flexible, remote role.
In this role, you will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities worldwide, ensuring adherence to all applicable guidelines and regulations. You will monitor regulatory changes and provide strategic advice to product development teams regarding regulatory requirements. Key responsibilities include managing post-approval regulatory activities, such as variations, renewals, and labeling updates. You will also collaborate with R&D, clinical, manufacturing, and marketing departments to ensure alignment on regulatory strategies and timelines.
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field, with advanced degrees or certifications in Regulatory Affairs being highly desirable. A minimum of 8 years of experience in pharmaceutical regulatory affairs is required, with a strong understanding of global regulatory submission processes (e.g., CTD, eCTD) and familiarity with major health authority requirements (e.g., FDA, EMA, PMDA). Excellent analytical, communication, and project management skills are essential, along with meticulous attention to detail. The ability to work independently and collaboratively within a remote team environment is crucial. This is an exceptional opportunity to make a significant impact on bringing life-saving medicines to patients worldwide, in a flexible, remote role.
This advertiser has chosen not to accept applicants from your region.
7
Remote Pharmaceutical Regulatory Affairs Specialist
30200 Moiben
KES140000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client is seeking a meticulous and knowledgeable Remote Pharmaceutical Regulatory Affairs Specialist to join our dedicated team. This is a fully remote position focused on ensuring our pharmaceutical products comply with all relevant national and international regulations. You will be responsible for preparing, submitting, and maintaining regulatory filings, including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and variations. This role requires a thorough understanding of regulatory pathways and guidelines within the pharmaceutical industry.
Key responsibilities include interpreting and applying regulatory requirements to product development and manufacturing processes. You will conduct regulatory intelligence activities, staying updated on changes in legislation and guidance documents that may affect the company. Collaboration with R&D, clinical, manufacturing, and quality assurance departments is essential to ensure regulatory compliance throughout the product lifecycle. You will also prepare responses to queries from regulatory agencies and manage post-approval commitments.
The ideal candidate will possess excellent analytical and problem-solving skills, with a keen eye for detail. Strong written and verbal communication skills are crucial for interacting with regulatory authorities and internal teams. This is a fully remote role, requiring strong self-discipline, effective time management, and the ability to work autonomously. Proficiency in regulatory information management systems and electronic submission platforms is expected.
Qualifications include a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or advanced degree in a relevant field is a plus. A minimum of 4 years of experience in pharmaceutical regulatory affairs is required, with demonstrated experience in preparing and submitting regulatory dossiers. Knowledge of global regulatory requirements (e.g., FDA, EMA) is highly desirable. Join our team and play a vital role in bringing life-saving medicines to patients by ensuring rigorous adherence to regulatory standards, all from the convenience of your home office.
Key responsibilities include interpreting and applying regulatory requirements to product development and manufacturing processes. You will conduct regulatory intelligence activities, staying updated on changes in legislation and guidance documents that may affect the company. Collaboration with R&D, clinical, manufacturing, and quality assurance departments is essential to ensure regulatory compliance throughout the product lifecycle. You will also prepare responses to queries from regulatory agencies and manage post-approval commitments.
The ideal candidate will possess excellent analytical and problem-solving skills, with a keen eye for detail. Strong written and verbal communication skills are crucial for interacting with regulatory authorities and internal teams. This is a fully remote role, requiring strong self-discipline, effective time management, and the ability to work autonomously. Proficiency in regulatory information management systems and electronic submission platforms is expected.
Qualifications include a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or advanced degree in a relevant field is a plus. A minimum of 4 years of experience in pharmaceutical regulatory affairs is required, with demonstrated experience in preparing and submitting regulatory dossiers. Knowledge of global regulatory requirements (e.g., FDA, EMA) is highly desirable. Join our team and play a vital role in bringing life-saving medicines to patients by ensuring rigorous adherence to regulatory standards, all from the convenience of your home office.
This advertiser has chosen not to accept applicants from your region.
8
Remote Pharmaceutical Regulatory Affairs Specialist
80100 Nairobi, Nairobi
KES95000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking a dedicated and experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This position is crucial for ensuring compliance with all relevant national and international pharmaceutical regulations. You will be responsible for preparing, reviewing, and submitting regulatory documentation, managing regulatory filings, and liaising with health authorities from a fully remote environment. Your in-depth knowledge of drug development processes and regulatory pathways will be vital for the successful registration and lifecycle management of pharmaceutical products.
Key Responsibilities:
Key Responsibilities:
- Prepare and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities in target markets.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Monitor and interpret evolving regulatory guidelines and provide strategic advice to internal stakeholders.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise effectively with regulatory agencies, responding to queries and facilitating the review process.
- Develop and maintain regulatory strategies for new and existing pharmaceutical products.
- Conduct regulatory intelligence gathering and analysis to identify potential risks and opportunities.
- Collaborate with cross-functional teams, including R&D, clinical affairs, quality assurance, and marketing.
- Maintain regulatory databases and ensure accurate record-keeping.
- Ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) from a regulatory perspective.
This advertiser has chosen not to accept applicants from your region.
9