Job Description
Position:Regulatory Affairs Specialist
Company:Pfizer Senegal
Location:Kaolack, Senegal
Experience:3-5 years in pharmaceutical regulatory affairs
Education:Bachelor’s degree in Pharmacy, Life Sciences or related field; Master’s preferred
Employment Type:Full-time
Industry:Pharmaceuticals
Department:Regulatory Affairs
Salary:1,200,000 – 1,800,000 SSP per month
Vacancies:1
Company Overview
Pfizer is a global leader in innovative medicines, vaccines and consumer health products, with a strong commitment to improving health outcomes across Africa. In Senegal, Pfizer operates a regional hub that supports the distribution of life‑saving therapies, collaborates with local health authorities, and invests in community health initiatives. The Kaolack office serves as a strategic center for regulatory coordination, ensuring that all products meet the highest standards of safety, efficacy and compliance. As part of Pfizer’s mission to bring breakthroughs that change patients’ lives, the company fosters a culture of scientific excellence, ethical conduct and continuous learning. Join a world‑renowned organization that values diversity, inclusion and the professional growth of its employees while contributing to the health of Senegalese communities.
Job Overview
The Regulatory Affairs Specialist will be responsible for managing the preparation, submission and maintenance of regulatory dossiers for Pfizer’s pharmaceutical portfolio in Senegal. This role acts as the primary liaison between Pfizer, the National Agency for the Safety of Medicines and Health Products (ANSM), and other governmental bodies. The specialist will ensure that all regulatory activities comply with local laws, regional guidelines and global Pfizer standards. By providing expert regulatory guidance, the incumbent will support product launches, post‑approval variations, and compliance audits, thereby facilitating timely market access and safeguarding public health. For more information about career opportunities, visit our main portal.
Key Responsibilities
- Prepare, review and submit registration dossiers for new medicines, generics and biosimilars in accordance with Senegalese regulations.
- Maintain and update product licensing files, ensuring all post‑approval changes are documented and communicated.
- Coordinate with cross‑functional teams including Clinical, Quality, Manufacturing and Marketing to gather required regulatory information.
- Monitor regulatory intelligence, assess impact of legislative changes, and advise internal stakeholders on compliance strategies.
- Represent Pfizer in meetings with ANSM and other health authorities, facilitating clear and effective communication.
- Develop and implement regulatory strategies that align with business objectives and market timelines.
- Support internal audits and inspections by providing necessary documentation and evidence of compliance.
- Prepare regulatory risk assessments and mitigation plans for ongoing and upcoming projects.
Required Skills
- In‑depth knowledge of Senegalese pharmaceutical regulations and international guidelines (e.g., ICH, WHO).
- Strong analytical and problem‑solving abilities with attention to detail.
- Excellent written and verbal communication skills in French and English.
- Proficiency in regulatory submission software and Microsoft Office suite.
- Ability to work collaboratively in a multicultural environment.
- Project management skills with the capacity to handle multiple dossiers simultaneously.
Education
A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life‑science discipline is required. A Master’s degree or professional certification in Regulatory Affairs is highly desirable. Candidates must demonstrate a solid understanding of drug development processes and regulatory pathways.
Experience
Applicants should have at least three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African markets. Experience in dossier preparation, submission, and interaction with health authorities is essential.
Salary
The position offers a competitive salary range of 1,200,000 to 1,800,000 SSP per month, commensurate with experience and qualifications. Additional performance‑based incentives may be provided.
Benefits
- Comprehensive health insurance covering medical, dental and vision.
- Retirement savings plan with company matching contributions.
- Paid annual leave and public holidays in accordance with Senegalese labor law.
- Professional development allowance for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering Pfizer’s global regulatory policies and local compliance requirements.
- Continuous learning modules on regulatory updates, pharmacovigilance and quality systems.
- Mentorship opportunities with senior regulatory leaders across the region.
Working Environment
Pfizer’s Kaolack office provides a modern, collaborative workspace equipped with the latest technology to support regulatory activities. The culture emphasizes teamwork, innovation and respect for diverse perspectives. Employees enjoy a balanced work‑life environment with flexible working arrangements where applicable.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through our online portal. Applications will be reviewed by the Talent Acquisition team, and shortlisted candidates will be contacted for a virtual interview. For additional resources on job search in the region, please visit the following site.
https://www.moroccojobsearch.com/
Equal Opportunity Statement
Pfizer Senegal is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, age, disability, sexual orientation or veteran status. All qualified applicants will receive consideration for employment.