Regulatory Affairs Manager Job Vacancy in Port Harcourt, Nigeria – Pharmaceuticals & Healthcare
Job Description
Position:Regulatory Affairs Manager
Company:Pfizer Nigeria
Location:Port Harcourt, Nigeria
Experience:5+ years in regulatory affairs within pharmaceutical industry
Education:Bachelor’s degree in Pharmacy, Chemistry, or related field; Master’s preferred
Employment Type:Full-time
Industry:Pharmaceuticals & Healthcare
Department:Regulatory Affairs
Salary:₦2,500,000 – ₦3,500,000 per annum
Vacancies:1
Company Overview
Pfizer Nigeria is a leading global biopharmaceutical company dedicated to improving health outcomes across Africa. With a strong presence in Port Harcourt, the company focuses on research, development, manufacturing, and distribution of innovative medicines and vaccines. As part of Pfizer’s worldwide network, the Nigerian subsidiary adheres to the highest standards of quality, compliance, and ethical conduct. The organization offers a dynamic environment where professionals can contribute to life‑saving therapies while advancing their careers. Join a team that values scientific excellence, collaboration, and a commitment to the communities it serves, making it a top choice for Nigeria Jobs seekers.
Job Overview
The Regulatory Affairs Manager will lead the development and execution of regulatory strategies for Pfizer Nigeria’s product portfolio. This role ensures that all pharmaceutical products meet local and international regulatory requirements, facilitating timely approvals and market access. The manager will act as the primary liaison with the National Agency for Food and Drug Administration and Control (NAFDAC) and other health authorities, guiding cross‑functional teams through complex regulatory landscapes. This position offers a unique opportunity to influence public health outcomes while working within a globally recognized organization.
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Key Responsibilities
- Develop and implement regulatory submission strategies for new drug applications, variations, and renewals.
- Prepare, review, and submit dossiers to NAFDAC and other relevant authorities, ensuring accuracy and compliance.
- Maintain up‑to‑date knowledge of Nigerian and international regulatory guidelines, including ICH, WHO, and EMA standards.
- Collaborate with R&D, Clinical, Manufacturing, and Quality Assurance teams to align product development with regulatory expectations.
- Lead internal audits and inspections, addressing findings and implementing corrective actions.
- Represent Pfizer Nigeria in regulatory meetings, workshops, and industry forums.
- Monitor post‑marketing surveillance data and manage product labeling updates.
- Provide regulatory training and mentorship to junior staff and cross‑functional colleagues.
Required Skills
- In‑depth understanding of Nigerian pharmaceutical regulations and global regulatory frameworks.
- Strong analytical and problem‑solving abilities with attention to detail.
- Excellent written and verbal communication skills for drafting technical documents and interacting with authorities.
- Project management expertise, capable of handling multiple submissions simultaneously.
- Proficiency in regulatory software tools and Microsoft Office Suite.
- Leadership qualities with the ability to influence and guide multidisciplinary teams.
Education
A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline is required. A Master’s degree or professional certification (e.g., RAC, RAPS) is highly desirable and demonstrates a commitment to regulatory excellence.
Experience
Candidates must have at least five years of progressive experience in regulatory affairs within the pharmaceutical industry, preferably with a track record of successful product registrations in Nigeria and other African markets.
Salary
The compensation package ranges from ₦2,500,000 to ₦3,500,000 annually, commensurate with experience and qualifications. The package includes performance‑based bonuses and comprehensive benefits.
Benefits
- Health insurance covering employee and dependents.
- Retirement savings plan with company matching contributions.
- Paid annual leave, sick leave, and public holidays.
- Professional development allowance for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering Pfizer’s compliance culture and regulatory processes.
- Continuous learning opportunities through internal webinars, external workshops, and mentorship.
- Access to Pfizer’s global knowledge platform for regulatory updates and best practices.
Working Environment
Pfizer Nigeria offers a collaborative, inclusive, and safety‑focused workplace. The office in Port Harcourt is equipped with modern facilities, and employees benefit from flexible working arrangements where applicable. The company promotes a culture of respect, diversity, and continuous improvement, aligning with global standards and local values.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their regulatory experience through the online portal on the Pfizer Careers website. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for interviews.
Equal Opportunity Statement
Pfizer Nigeria is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, disability, or any other protected characteristic. Join us and be part of a team that drives health innovation across Nigeria and beyond.
