Job Description
Position: Regulatory Affairs Specialist
Company: Pfizer Inc.
Location: Baidoa, Somalia
Experience: 3-5 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
Department: Regulatory Affairs
Salary: SSP 2,500,000 – SSP 3,500,000 per annum
Vacancies:1
Company Overview
Pfizer Inc. is a global leader in innovative medicines, vaccines, and consumer health products, committed to improving health outcomes worldwide. With a strong presence across Africa, Pfizer brings cutting‑edge research, development, and manufacturing capabilities to local markets, fostering partnerships that enhance access to life‑saving therapies. In Somalia, Pfizer collaborates with health ministries, NGOs, and private sector partners to support disease prevention, treatment programs, and capacity building. As part of its mission to deliver breakthroughs that change patients’ lives, Pfizer offers dynamic career pathways for professionals eager to make a tangible impact on public health in emerging markets.
Job Overview
The Regulatory Affairs Specialist will play a pivotal role in ensuring that Pfizer’s pharmaceutical products comply with all applicable Somali regulations and international standards. This position involves preparing and submitting dossiers, liaising with the Ministry of Health, and monitoring regulatory changes that affect product registration and market access. The specialist will work closely with cross‑functional teams, including Clinical Development, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. Candidates will contribute to the successful launch and lifecycle management of medicines that address critical health needs in Somalia. For more information about our commitment to local talent, visit Somalia Job Search.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for new drug applications, variations, and renewals in compliance with Somali Ministry of Health guidelines.
- Maintain up‑to‑date knowledge of national and regional regulatory requirements, including WHO pre‑qualification processes.
- Coordinate with internal stakeholders to gather necessary scientific, clinical, and manufacturing data for submissions.
- Serve as the primary point of contact with regulatory authorities, facilitating inspections and responding to queries.
- Develop and implement regulatory strategies that support timely product launches and market expansion.
- Monitor post‑approval commitments, adverse event reporting, and product labeling updates.
- Provide regulatory guidance during product development, ensuring alignment with compliance standards.
- Prepare regulatory intelligence reports and advise senior management on potential impacts.
Required Skills
- Strong understanding of pharmaceutical regulatory frameworks in Somalia and the East African region.
- Excellent written and verbal communication skills in English; proficiency in Somali is an advantage.
- Analytical mindset with the ability to interpret complex scientific data.
- Proficiency in regulatory submission software and document management tools.
- Effective project management and multitasking abilities.
- Collaborative team player with strong stakeholder management skills.
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 in Regulatory Affairs (e.g., RAC) is highly desirable and will be considered an asset during the selection process.
Experience
Applicants should possess three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African regulatory environments. Experience in preparing dossiers for WHO pre‑qualification or similar international programs is advantageous.
Salary
The compensation package ranges from SSP 2,500,000 to SSP 3,500,000 annually, commensurate with experience and qualifications. The package includes performance‑based incentives, health insurance, and pension contributions.
Benefits
- Comprehensive health and dental coverage for employee and dependents.
- Retirement savings plan with employer matching.
- Annual performance bonus linked to individual and company goals.
- Paid parental and compassionate leave.
- Professional development allowance for certifications and conferences.
Training
- On‑boarding program covering Pfizer’s global compliance standards and local regulatory landscape.
- Continuous learning opportunities through internal e‑learning platforms and external workshops.
- Mentorship from senior regulatory leaders to accelerate career growth.
Working Environment
Pfizer offers a collaborative, inclusive workplace that values diversity and innovation. The Baidoa office provides modern facilities, flexible working arrangements, and a culture that encourages knowledge sharing and employee well‑being. Employees are empowered to contribute ideas that drive business success and improve health outcomes across Somalia.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on our website. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for virtual interviews. Please ensure all documents are uploaded in PDF format.
Equal Opportunity Statement
Pfizer is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. Join us in shaping the future of healthcare in Somalia.