29 Senior Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is actively searching for a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in a fully remote capacity. This crucial role will involve navigating the complex landscape of pharmaceutical regulations, ensuring compliance with national and international health authority requirements for drug development and marketing. You will be responsible for preparing, reviewing, and submitting regulatory documentation, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and variations. The ideal candidate will possess a deep understanding of pharmaceutical sciences, extensive knowledge of regulatory guidelines (e.g., FDA, EMA, WHO), and a proven ability to interpret and apply regulatory strategies effectively. You will engage with regulatory agencies, respond to queries, and manage post-approval regulatory activities. This position requires meticulous attention to detail, excellent analytical and problem-solving skills, and strong written and verbal communication abilities. You will collaborate closely with R&D, clinical affairs, quality assurance, and commercial teams to ensure regulatory strategies align with business objectives. As a remote-first role, you must be highly self-motivated, organized, and proficient in utilizing digital communication and collaboration tools. The ability to manage multiple projects simultaneously and meet stringent deadlines is essential. We are looking for a strategic thinker who can provide expert regulatory guidance, identify potential risks, and develop proactive solutions to ensure timely product approvals and market access. This is an exceptional opportunity for a dedicated professional to contribute significantly to bringing life-saving medicines to patients worldwide, all while enjoying the flexibility of a remote work environment. Your expertise will be vital in shaping the regulatory pathway for innovative pharmaceutical products.
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 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.
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This role is essential for ensuring compliance with global regulatory standards and for successfully navigating the complex landscape of drug approvals and lifecycle management. The ideal candidate will possess a strong understanding of pharmaceutical regulations, a meticulous attention to detail, and excellent communication skills to liaise with health authorities and internal stakeholders. This remote position requires a self-motivated individual who can manage multiple regulatory submissions and projects concurrently while maintaining the highest standards of quality and integrity.
Responsibilities:
Required Qualifications:
This is a rewarding remote role for a dedicated regulatory professional looking to make a significant contribution to bringing vital medicines to patients.
Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, ANDA) to health authorities worldwide.
- Interpret and advise on regulatory requirements and guidelines for drug development, manufacturing, and marketing.
- Develop regulatory strategies to support product development and commercialization plans.
- Liaise with regulatory agencies (e.g., FDA, EMA, local authorities) on submissions, inquiries, and meetings.
- Manage post-approval regulatory activities, including variations, annual reports, and renewals.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Review promotional materials and labeling for regulatory compliance.
- Collaborate with R&D, Clinical, Quality Assurance, and Commercial teams to ensure regulatory requirements are met throughout the product lifecycle.
- Monitor regulatory intelligence and update company policies and procedures accordingly.
- Provide training to internal teams on regulatory requirements and best practices.
- Assess the regulatory impact of proposed product changes or new developments.
- Maintain accurate and organized regulatory records and databases.
Required Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- A minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations (e.g., ICH guidelines, US FDA, EMA).
- Proven experience in preparing and submitting various types of regulatory dossiers.
- Excellent understanding of drug development processes and product lifecycle management.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Exceptional written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
- Ability to work independently, manage priorities effectively, and meet strict deadlines in a remote setting.
- Strong interpersonal skills and the ability to collaborate effectively with diverse teams.
- Experience with regulatory information management systems is a plus.
- Pharmaceutical industry experience is mandatory.
This is a rewarding remote role for a dedicated regulatory professional looking to make a significant contribution to bringing vital medicines to patients.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading global pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote regulatory team. This position is critical for ensuring compliance with all relevant pharmaceutical regulations and guidelines across various international markets. The ideal candidate will possess a strong understanding of drug development processes, regulatory submission requirements, and post-market surveillance. You will play a key role in strategizing and executing regulatory submissions, interacting with health authorities, and ensuring the timely approval and market access of pharmaceutical products.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for new drug applications (NDAs) and marketing authorization applications (MAAs).
- Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, MHRA).
- Liaise directly with regulatory agencies, responding to queries and facilitating communication.
- Ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP).
- Monitor and interpret evolving regulatory landscapes and provide guidance to internal teams.
- Manage post-approval regulatory activities, including variations, renewals, and labeling updates.
- Conduct regulatory intelligence gathering and competitive analysis.
- Provide regulatory input into product development, clinical trial design, and manufacturing processes.
- Develop and maintain regulatory documentation and databases.
- Support due diligence activities for potential acquisitions and partnerships.
- Collaborate with cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Train and mentor junior regulatory affairs professionals.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting successful regulatory dossiers for various therapeutic areas.
- In-depth knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Experience in managing regulatory submissions for biologics or complex molecules is a plus.
- Strong understanding of drug development lifecycle and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Exceptional written and verbal communication skills, with proficiency in technical writing.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.
- Proficiency in regulatory information management systems is advantageous.
- Strong negotiation and interpersonal skills for effective interaction with health authorities.
- Commitment to ethical conduct and regulatory compliance.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is searching for an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their esteemed, fully remote team. This critical position involves ensuring compliance with all national and international pharmaceutical regulations governing drug development, manufacturing, and marketing. You will be responsible for preparing and submitting regulatory filings, liaising with health authorities, and providing expert guidance on regulatory strategies. This is a remote role, demanding meticulous attention to detail, exceptional analytical skills, and strong virtual communication capabilities to collaborate effectively with R&D, manufacturing, and commercial departments.
Key Responsibilities:
The ideal candidate will possess a strong scientific background (e.g., Pharmacy, Chemistry, Biology) and a minimum of 5-7 years of experience in pharmaceutical regulatory affairs. A deep understanding of global regulatory requirements and a proven track record of successful regulatory submissions are essential. Excellent written and verbal communication skills, along with the ability to work independently and collaboratively in a remote setting, are key requirements for this role.
Key Responsibilities:
- Develop and implement regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals.
- Serve as the primary point of contact for health authorities (e.g., FDA, EMA, local regulatory bodies).
- Monitor regulatory changes and assess their impact on the company's product portfolio and operations.
- Provide regulatory guidance and support to cross-functional teams throughout the product development process.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations.
- Review promotional materials and labeling for regulatory compliance.
- Manage post-approval regulatory activities, including safety reporting and annual reports.
- Conduct regulatory intelligence assessments to identify emerging trends and opportunities.
- Contribute to the development of internal SOPs and policies related to regulatory affairs.
The ideal candidate will possess a strong scientific background (e.g., Pharmacy, Chemistry, Biology) and a minimum of 5-7 years of experience in pharmaceutical regulatory affairs. A deep understanding of global regulatory requirements and a proven track record of successful regulatory submissions are essential. Excellent written and verbal communication skills, along with the ability to work independently and collaboratively in a remote setting, are key requirements for this role.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a distinguished pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory strategy and submissions. This position is fully remote, allowing you to contribute to global pharmaceutical compliance from your chosen location. You will be responsible for managing the entire regulatory lifecycle for pharmaceutical products, from early-stage development through to post-market surveillance. Your core duties will include developing regulatory strategies, preparing and submitting comprehensive dossiers to health authorities worldwide (e.g., FDA, EMA, local regulatory bodies), and ensuring compliance with all applicable regulations and guidelines. You will also liaise with regulatory agencies, respond to queries, and manage regulatory change controls. The ideal candidate will possess a profound understanding of pharmaceutical development, manufacturing processes, and global regulatory requirements. Exceptional analytical, problem-solving, and communication skills are critical. A bachelor's or master's degree in Pharmacy, Chemistry, Biology, or a related life science field is required, along with a minimum of 7 years of progressive experience in pharmaceutical regulatory affairs. Experience with a variety of dosage forms and therapeutic areas is highly advantageous. Knowledge of ICH guidelines and regional regulatory specificities is essential. This remote role offers a competitive salary and benefits, along with the opportunity to work on innovative medicines and make a significant contribution to global health. You will be a key advisor on regulatory strategy and ensure timely approvals for our client's products. We are looking for a proactive and detail-oriented professional who can navigate the complex and evolving regulatory landscape. Your ability to anticipate regulatory challenges and develop effective submission strategies will be crucial for success. This is an excellent opportunity for a seasoned regulatory affairs expert to excel in a remote capacity.
This advertiser has chosen not to accept applicants from your region.
5
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading global pharmaceutical company dedicated to advancing healthcare through innovative medicines, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their esteemed, fully remote team. This role is critical in ensuring the timely and successful registration of pharmaceutical products in various international markets. As a Senior Specialist, you will be responsible for developing and implementing global regulatory strategies, preparing and submitting regulatory dossiers, and maintaining strong relationships with health authorities worldwide. You will stay abreast of evolving regulatory landscapes, guidances, and best practices across key regions, ensuring compliance and facilitating market access for our client's innovative pipeline. The ideal candidate will possess a deep understanding of pharmaceutical product development, manufacturing processes, and global regulatory requirements. You should be adept at interpreting complex scientific and technical data and translating it into compelling regulatory submissions. This remote position requires exceptional analytical, problem-solving, and strategic thinking skills, coupled with outstanding written and verbal communication abilities. You will collaborate closely with cross-functional teams, including R&D, clinical affairs, manufacturing, and quality assurance, to ensure alignment and facilitate the smooth progression of regulatory activities. If you are a seasoned regulatory affairs professional with a passion for bringing life-changing medications to patients globally and thrive in a flexible, remote work environment, this challenging and rewarding opportunity is for you.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities.
- Liaise with regulatory agencies to address inquiries and facilitate product approvals.
- Monitor and interpret global regulatory requirements and guidances.
- Provide regulatory input throughout the product lifecycle, from early development to post-marketing.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Manage post-approval regulatory submissions and lifecycle management activities.
- Assess the regulatory impact of manufacturing changes and product variations.
- Contribute to the development of regulatory policies and procedures.
- Mentor junior regulatory affairs personnel.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science. A Master's degree or relevant professional certification is highly desirable.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting successful regulatory dossiers for various product types.
- In-depth knowledge of global regulatory guidelines and requirements (e.g., ICH, FDA, EMA).
- Strong understanding of pharmaceutical development, manufacturing, and quality assurance.
- Excellent analytical, strategic thinking, and problem-solving skills.
- Exceptional written and verbal communication skills.
- Ability to manage multiple projects and meet tight deadlines in a remote setting.
- Strong negotiation and influencing skills.
- High level of attention to detail and accuracy.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking an accomplished Senior Pharmaceutical Regulatory Affairs Specialist to manage and oversee all aspects of regulatory compliance for their product portfolio. This is a critical, fully remote role demanding a deep understanding of global pharmaceutical regulations and a proven ability to navigate complex submission processes. The successful candidate will be responsible for ensuring that all products meet the stringent requirements set forth by health authorities worldwide, thereby facilitating market access and maintaining product integrity. This position requires meticulous attention to detail, exceptional analytical skills, and strong communication abilities.
Key Responsibilities:
Qualifications:
This is an exceptional remote opportunity to contribute significantly to pharmaceutical compliance from your base near **Machakos, Machakos, KE**, ensuring global standards are met.
Key Responsibilities:
- Develop and implement regulatory strategies to support product development, registration, and lifecycle management.
- Prepare and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities in target markets.
- Interpret and communicate regulatory requirements and guidelines to internal teams, including R&D, manufacturing, and marketing.
- Review and approve promotional materials, labeling, and packaging to ensure compliance with regulatory standards.
- Manage post-approval changes and ensure timely notification or submission to regulatory agencies.
- Respond to queries from health authorities and facilitate regulatory inspections.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
- Conduct regulatory intelligence activities to identify emerging trends and opportunities.
- Collaborate with cross-functional teams to ensure that regulatory considerations are integrated into product development and commercialization plans.
- Maintain comprehensive regulatory documentation and databases.
- Provide guidance and training to relevant personnel on regulatory affairs matters.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Thorough knowledge of global regulatory requirements (e.g., FDA, EMA, WHO) and submission processes.
- Proven experience in preparing and submitting regulatory dossiers.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote environment.
- Proficiency in regulatory information management systems and document management systems.
- Detail-oriented with a high degree of accuracy.
- Experience in specific therapeutic areas is a plus.
This is an exceptional remote opportunity to contribute significantly to pharmaceutical compliance from your base near **Machakos, Machakos, KE**, ensuring global standards are met.
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. This critical role involves ensuring compliance with all relevant national and international pharmaceutical regulations, overseeing the submission of new drug applications, and maintaining existing product registrations. You will be responsible for interpreting complex regulatory guidelines, developing regulatory strategies, and liaising with health authorities. The ideal candidate will possess extensive knowledge of the pharmaceutical industry, a deep understanding of regulatory affairs principles, and a proven track record of successfully navigating regulatory pathways. Your responsibilities will include preparing and reviewing regulatory submission documents, managing post-approval changes, and staying abreast of evolving regulatory landscapes. Strong analytical, communication, and project management skills are essential, as you will work cross-functionally with R&D, manufacturing, and commercial teams, primarily through digital channels. This is a 100% remote role, offering the flexibility to work from anywhere in Kenya. We are looking for a detail-oriented, proactive individual who can work independently, manage multiple priorities, and contribute to the company's strategic objectives. Experience with regulatory affairs in emerging markets is a significant advantage. This is an exceptional opportunity to apply your regulatory expertise to impactful pharmaceutical projects and drive the success of innovative medicines within a flexible, remote work environment. If you are a dedicated regulatory affairs professional looking for a challenging and rewarding remote career, we invite you to apply.
This advertiser has chosen not to accept applicants from your region.
8
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Regulatory Affairs Specialist to join their globally distributed, remote-first regulatory team. This critical role is responsible for ensuring that all pharmaceutical products comply with national and international regulations and guidelines, from development through to market approval and post-market surveillance. You will play a pivotal role in developing regulatory strategies, preparing submission dossiers, and liaising with health authorities. The ideal candidate possesses a profound understanding of pharmaceutical R&D, manufacturing processes, and the complex regulatory landscape governing drug development. You must have exceptional attention to detail, strong analytical skills, and the ability to interpret and apply intricate regulations. This is a fully remote position, demanding superior organizational skills, proactive communication, and the ability to manage complex projects independently. Key responsibilities include:
- Developing and executing global regulatory strategies for new and existing pharmaceutical products.
- Preparing, reviewing, and submitting regulatory dossiers (e.g., IND, NDA, MAA) to health authorities worldwide.
- Interpreting and applying relevant pharmaceutical regulations, guidelines, and standards.
- Serving as the primary point of contact with regulatory agencies, responding to queries and managing interactions.
- Monitoring changes in the regulatory environment and assessing their impact on the company's products and strategies.
- Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Providing regulatory guidance and support to cross-functional teams, including R&D, manufacturing, marketing, and legal.
- Conducting regulatory intelligence activities to identify opportunities and mitigate risks.
- Managing the lifecycle of regulatory approvals and ensuring timely post-approval maintenance.
- Reviewing promotional materials and labeling for regulatory compliance.
- Participating in regulatory audits and inspections.
This advertiser has chosen not to accept applicants from your region.
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