766 Senior Regulatory Affairs Specialist Pharmaceuticals jobs in Kenya
Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company dedicated to improving global health outcomes, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their remote team. This critical role involves ensuring compliance with all relevant national and international regulations for our client's pharmaceutical products.
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
- Manage and maintain product registrations and licenses, ensuring timely renewals and compliance with post-approval commitments.
- Interpret and advise on complex regulatory requirements, guidelines, and changes affecting pharmaceutical products.
- Develop regulatory strategies for new product development and lifecycle management.
- Act as the primary point of contact for regulatory health authorities, addressing inquiries and facilitating communication.
- Review and approve labeling, promotional materials, and advertising for compliance with regulations.
- Conduct regulatory intelligence activities to monitor evolving legislation and provide proactive guidance.
- Collaborate with R&D, Quality Assurance, Clinical Affairs, and Commercial departments to ensure regulatory compliance throughout the product lifecycle.
- Identify and assess regulatory risks and develop mitigation strategies.
- Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs).
- Mentor junior regulatory affairs personnel.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. Advanced degree (Master's or PharmD) is preferred.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals across multiple global markets.
- In-depth knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA, WHO).
- Experience with electronic submission portals and regulatory information management systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management abilities and the capacity to manage multiple complex projects simultaneously.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
- Ability to work independently and collaboratively in a fast-paced, remote environment.
- High ethical standards and commitment to compliance.
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
This advertiser has chosen not to accept applicants from your region.
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Lead Regulatory Affairs Specialist, Pharmaceutical Compliance
Posted 20 days ago
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Job Description
Our client, a dynamic and expanding biopharmaceutical company, is seeking a highly experienced Lead Regulatory Affairs Specialist to join their globally distributed, fully remote team. This senior position plays a crucial role in ensuring the company's compliance with all relevant pharmaceutical regulations for drug development, manufacturing, and marketing. You will be responsible for developing and executing regulatory strategies for new product submissions, managing post-approval changes, and maintaining regulatory filings. Your expertise will guide the company through complex regulatory landscapes across various international markets. You will lead interactions with regulatory agencies, prepare submission dossiers (e.g., CTD format), and provide strategic advice to internal R&D, clinical, and commercial teams. The ideal candidate will have a deep understanding of global pharmaceutical regulations, guidelines (ICH), and quality systems. Proven experience in successfully navigating regulatory pathways for new drug applications (NDAs) or marketing authorizations is essential. This role requires strong leadership capabilities, excellent analytical and problem-solving skills, and the ability to manage multiple projects simultaneously in a high-pressure environment. You will mentor junior regulatory affairs personnel and contribute to shaping the company's regulatory compliance framework. This is an exceptional opportunity to influence drug approvals and contribute to bringing life-saving therapies to patients worldwide, all from a remote work setting.
Key Responsibilities:
Key Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical products.
- Prepare and manage the submission of regulatory dossiers (e.g., INDs, NDAs, MAAs) in various regions.
- Lead communication and interactions with global health authorities (e.g., FDA, EMA, MHRA).
- Oversee post-approval regulatory activities, including variations, renewals, and compliance reporting.
- Provide regulatory guidance and support to R&D, clinical development, manufacturing, and commercial teams.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Conduct regulatory intelligence activities and assess the impact of new regulations.
- Manage and mentor junior regulatory affairs specialists.
- Participate in regulatory inspections and audits.
- Contribute to the development and improvement of regulatory processes and systems.
- Advanced degree (e.g., Master's, PhD) in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets.
- In-depth knowledge of global pharmaceutical regulations, guidelines (ICH), and compliance requirements.
- Experience with Common Technical Document (CTD) format.
- Strong leadership, project management, and organizational skills.
- Excellent written and verbal communication and negotiation skills.
- Ability to analyze complex scientific and regulatory information.
- Experience working in a fully remote or geographically dispersed team is highly desirable.
- Familiarity with pharmacovigilance and quality assurance principles.
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Senior Regulatory Affairs Specialist - Pharmaceuticals - Remote
Posted 10 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their globally distributed team. This is a crucial, fully remote position focused on ensuring compliance with pharmaceutical regulations across various international markets. You will be responsible for developing and executing regulatory strategies for product approvals, managing submissions, and maintaining regulatory compliance throughout the product lifecycle. Your expertise will guide the company through complex regulatory landscapes, ensuring timely market access for innovative therapies. Key responsibilities include preparing and submitting marketing authorization applications (MAAs), responding to regulatory agency queries, and staying abreast of evolving regulatory requirements. You will collaborate closely with R&D, clinical, manufacturing, and commercial teams to ensure regulatory alignment and success. The ideal candidate possesses a deep understanding of pharmaceutical regulations, strong analytical skills, and the ability to navigate diverse regulatory frameworks.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for new drug applications and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD format) for marketing authorization applications (MAAs) in various regions.
- Serve as the primary liaison with regulatory authorities, responding to agency inquiries and facilitating communication.
- Ensure ongoing compliance with post-approval regulatory commitments and reporting requirements.
- Monitor and interpret changes in the global regulatory landscape and assess their impact on the company's product portfolio.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing.
- Evaluate regulatory risks and opportunities associated with product development and commercialization.
- Manage variations and amendments to approved marketing authorizations.
- Contribute to the development of regulatory policies and procedures.
- Conduct regulatory intelligence activities to identify emerging trends and competitor strategies.
- Mentor and train junior regulatory affairs professionals.
Qualifications:
- Master's degree or Ph.D. in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting MAAs in major markets (e.g., EMA, FDA, PPB).
- Thorough understanding of ICH guidelines and regional pharmaceutical regulatory requirements.
- Excellent scientific, analytical, and problem-solving skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines.
- Proficiency in regulatory information management systems and electronic submission platforms.
- Strong interpersonal skills and the ability to collaborate effectively with internal teams and external stakeholders.
- Experience working effectively in a remote, international team environment.
This advertiser has chosen not to accept applicants from your region.
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Regulatory Affairs Specialist - Pharmaceutical Compliance
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly detail-oriented and experienced Regulatory Affairs Specialist to ensure compliance with all relevant regulations and guidelines. This role operates on a hybrid model, allowing for a blend of remote work and on-site collaboration. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field, with a demonstrated track record in pharmaceutical regulatory affairs. You will be responsible for preparing, submitting, and maintaining regulatory filings for new and existing pharmaceutical products in various global markets. This includes authoring submission documents, responding to regulatory agency queries, and ensuring that all product information and labeling comply with current regulations. You will stay abreast of evolving regulatory landscapes, assess the impact of new regulations on company products and processes, and provide strategic regulatory guidance to internal teams. Collaboration with R&D, manufacturing, quality assurance, and marketing departments is crucial to ensure seamless integration of regulatory requirements into product lifecycle management. Experience with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant international regulatory guidelines (e.g., FDA, EMA) is essential. Strong analytical, problem-solving, and project management skills are required, along with excellent written and verbal communication abilities. The capacity to manage multiple projects simultaneously and meet strict deadlines is critical. We are looking for a meticulous and proactive professional who is committed to ensuring the highest standards of pharmaceutical compliance. This role offers a challenging and rewarding opportunity to contribute to bringing safe and effective medicines to patients worldwide, with the flexibility of a hybrid work arrangement. Your expertise will be vital in navigating the complex regulatory environment of the pharmaceutical industry. The successful candidate will possess a strong understanding of drug development processes and regulatory submission requirements. This position, conceptually located in Kitale, Trans-Nzoia, KE , will be performed in a hybrid capacity.
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist - Pharmaceutical - Remote
Posted 10 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly proficient Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This critical role will involve managing all aspects of regulatory submissions and ensuring compliance with national and international pharmaceutical regulations. You will be responsible for preparing, reviewing, and submitting regulatory dossiers for drug product registrations, variations, and renewals. This includes ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). You will liaise with regulatory authorities, health ministries, and other relevant agencies to facilitate timely approvals and address queries. The ideal candidate will possess a strong understanding of the drug development lifecycle and extensive experience with regulatory submission processes in key markets. Expertise in navigating the regulatory landscape for pharmaceuticals, biologics, and medical devices is essential. You will stay updated on evolving regulatory requirements and provide strategic guidance to internal teams, including R&D, manufacturing, and marketing. This position demands exceptional attention to detail, strong analytical skills, and the ability to manage complex projects independently. Excellent written and verbal communication skills are vital for clear and effective interaction with both internal stakeholders and external regulatory bodies. As a fully remote role, you will need to be self-motivated and organized, capable of working autonomously while maintaining collaborative relationships with colleagues. This is an excellent opportunity to contribute to bringing vital medicines to patients worldwide from the convenience of your home. The role supports strategic initiatives within **Thika, Kiambu, KE**, but is a remote position.
This advertiser has chosen not to accept applicants from your region.
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Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, offering the flexibility to work from anywhere while contributing to critical regulatory submissions and strategies. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations. This includes preparing, compiling, and submitting regulatory dossiers for new drug applications, variations, and post-approval changes. The ideal candidate will possess a deep understanding of regulatory requirements across various markets, exceptional attention to detail, and strong scientific writing skills. You will liaise with regulatory authorities, manage submission timelines, and stay abreast of evolving regulatory landscapes. This role requires a proactive approach to identifying potential regulatory challenges and developing effective solutions. Collaboration with R&D, manufacturing, and quality assurance teams will be integral to your success. We are seeking an individual with a strong scientific background and a proven ability to navigate complex regulatory frameworks. If you are passionate about ensuring patient access to safe and effective medicines through expert regulatory guidance, this is an exceptional opportunity. This fully remote role supports operations relevant to the Naivasha, Nakuru, KE region.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals in accordance with global regulatory guidelines.
- Maintain a thorough understanding of current and emerging pharmaceutical regulations and guidelines in target markets.
- Liaise with national and international health authorities on regulatory submissions and inquiries.
- Assess the regulatory implications of product changes, manufacturing processes, and quality systems.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure compliance with labeling requirements and review promotional materials for regulatory accuracy.
- Manage the lifecycle of regulatory approvals and maintain regulatory documentation.
- Conduct regulatory intelligence activities to identify new requirements and opportunities.
- Participate in regulatory audits and inspections as required.
- Develop and implement regulatory strategies to support product development and lifecycle management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A higher degree or specialized certifications in Regulatory Affairs are highly desirable.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD, eCTD).
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Excellent scientific writing, analytical, and problem-solving skills.
- Strong attention to detail and accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate with diverse teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently and manage multiple projects in a remote setting.
This advertiser has chosen not to accept applicants from your region.
5
Lead Pharmaceutical Regulatory Affairs Specialist
Posted 17 days ago
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Job Description
Our client is seeking a highly experienced and strategic Lead Pharmaceutical Regulatory Affairs Specialist to join their fully remote global team. This pivotal role will oversee the regulatory strategy and execution for pharmaceutical products, ensuring compliance with international health authority regulations and guidelines. You will be responsible for preparing, submitting, and maintaining regulatory dossiers for drug approvals in various markets, managing post-approval changes, and providing expert guidance on regulatory requirements throughout the product lifecycle.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
Qualifications:
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
- Develop and implement comprehensive global regulatory strategies for new and existing pharmaceutical products.
- Lead the preparation and submission of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other marketing authorizations.
- Manage and maintain all regulatory filings, amendments, and renewals.
- Interpret and communicate complex regulatory requirements and guidelines to internal teams.
- Conduct regulatory intelligence activities to stay informed of evolving regulations and agency expectations.
- Oversee the regulatory review of labeling, promotional materials, and advertising.
- Liaise directly with health authorities (e.g., FDA, EMA, national agencies) on behalf of the company.
- Manage and mentor a team of regulatory affairs professionals, fostering their development and ensuring high performance.
- Contribute to the development and implementation of regulatory compliance programs.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree (Master's, Pharm.D., Ph.D.) strongly preferred.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements (ICH, FDA, EMA, etc.).
- Experience managing and leading regulatory affairs teams.
- Excellent written and verbal communication skills, with strong negotiation abilities.
- Exceptional analytical and problem-solving skills, with meticulous attention to detail.
- Demonstrated ability to work effectively in a fully remote, collaborative environment, managing multiple projects and deadlines.
- Proficiency with regulatory information management systems is a plus.
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
This advertiser has chosen not to accept applicants from your region.
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6
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
Our client is seeking a detail-oriented and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in a fully remote capacity. This vital role involves ensuring compliance with all relevant pharmaceutical regulations and guidelines throughout the product lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory agencies, and staying abreast of evolving regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical drug development, regulatory processes, and international regulatory frameworks. Key responsibilities include managing regulatory submissions (e.g., INDs, NDAs, MAAs), reviewing product labeling for compliance, assessing changes to approved products, and providing regulatory guidance to internal teams. You will also be involved in regulatory strategy development and risk assessment. Experience with specific therapeutic areas or drug classes is advantageous. This is an exceptional opportunity to make a significant contribution to patient access to safe and effective medicines, working from a remote environment with a leading pharmaceutical organization. You must possess excellent analytical, organizational, and communication skills, with a keen eye for detail. The ability to interpret complex regulations and apply them effectively to specific situations is crucial. A bachelor's or master's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biology) is required. This role demands a proactive approach, the ability to work independently, and strong collaboration skills to work effectively with cross-functional teams. The conceptual work location is **Mlolongo, Machakos, KE**, but the position is performed entirely remotely.
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7
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
Our client is seeking a highly knowledgeable and experienced Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory strategy and submissions for new drug products. This critical, fully remote position requires a deep understanding of global pharmaceutical regulations and a proven ability to navigate complex regulatory pathways. You will be responsible for developing and implementing regulatory strategies, preparing and submitting comprehensive regulatory dossiers to health authorities (e.g., FDA, EMA, CDSCO), and ensuring ongoing compliance throughout the product lifecycle. The ideal candidate will have extensive experience in the pharmaceutical industry, with a strong focus on regulatory affairs. Expertise in IND, NDA, ANDA, and MAA submissions, as well as post-approval lifecycle management, is essential. You must possess exceptional analytical, scientific writing, and communication skills, with the ability to interpret and apply complex regulatory guidelines. As a remote specialist, you will collaborate effectively with R&D, clinical affairs, quality assurance, and commercial teams, leveraging virtual collaboration tools to ensure seamless communication and alignment on regulatory objectives. We are looking for a proactive and detail-oriented professional who can anticipate regulatory challenges, provide strategic guidance, and drive successful product approvals in diverse international markets. This is an excellent opportunity to make a significant impact on global drug development and patient access from a flexible, remote work setting.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, ANDA, MAA) to health authorities worldwide.
- Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
- Manage and respond to queries from regulatory agencies during the review process.
- Oversee post-approval regulatory activities, including variations, renewals, and lifecycle management.
- Liaise with R&D, clinical, manufacturing, and quality assurance departments to gather necessary information for submissions.
- Provide regulatory guidance and support to project teams throughout the drug development process.
- Monitor changes in the regulatory landscape and assess their impact on company strategies.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
- Act as a key point of contact for regulatory authorities.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field; advanced degree (Master's or PhD) preferred.
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU).
- In-depth knowledge of regulatory requirements for small molecules, biologics, or generics.
- Experience with eCTD publishing and submission management systems.
- Excellent scientific writing, analytical, and critical thinking skills.
- Strong understanding of drug development processes and pharmaceutical manufacturing.
- Ability to manage multiple projects and meet tight deadlines in a remote environment.
- Excellent communication and interpersonal skills.
- Membership in relevant professional regulatory affairs associations is a plus.
This advertiser has chosen not to accept applicants from your region.
8
Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is actively seeking a highly experienced and detail-oriented Lead Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, allowing you to contribute from any location in Kenya. You will be instrumental in ensuring our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. This position demands a deep understanding of drug development, submission processes, and post-approval maintenance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to relevant health authorities.
- Monitor and interpret changes in pharmaceutical regulations and guidelines, providing proactive guidance to the organization.
- Liaise effectively with regulatory agencies, health authorities, and other stakeholders.
- Oversee the regulatory aspects of product lifecycle management, including variations, renewals, and amendments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Provide regulatory input and support for product development, clinical trials, and marketing authorization applications.
- Manage regulatory documentation and databases, ensuring accuracy and completeness.
- Lead and mentor junior regulatory affairs professionals, fostering a collaborative and expert team environment.
- Conduct regulatory intelligence activities to stay abreast of evolving global regulatory landscapes.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, KEBS).
- Proven experience in preparing and submitting marketing authorization applications.
- Demonstrated experience managing regulatory submissions for various therapeutic areas.
- Excellent understanding of drug development processes and regulatory pathways.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working in a remote or hybrid team setting is highly desirable.
This advertiser has chosen not to accept applicants from your region.
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