Regulatory Affairs Specialist Job Vacancy in Asmara, Eritrea – Pharmaceuticals
Job Description
Position:Regulatory Affairs Specialist
Company:Pfizer
Location:Asmara, Eritrea
Experience:3-5 years
Education:Bachelor’s degree in Pharmacy, Chemistry, or related field
Employment Type:Full-time
Industry:Pharmaceuticals
Department:Regulatory Affairs
Salary:150,000 – 250,000 SSP per month
Vacancies:1
Company Overview
Pfizer is a global leader in innovative medicines, vaccines, and consumer health products, dedicated to improving health outcomes worldwide. With a strong commitment to research and development, Pfizer operates in more than 150 countries, delivering life‑saving therapies across therapeutic areas. In Eritrea, Pfizer collaborates with local health authorities, distributors, and research institutions to ensure the availability of high‑quality pharmaceutical products. The company’s presence in Asmara reflects its strategic focus on expanding access to essential medicines in emerging markets, supporting national health initiatives, and fostering sustainable growth. As part of Pfizer’s mission, the Asmara office plays a pivotal role in navigating regulatory landscapes, ensuring compliance, and facilitating market entry for new products, thereby contributing to the broader goal of enhancing public health in Eritrea.
Job Overview
The Regulatory Affairs Specialist will serve as the primary liaison between Pfizer and Eritrean regulatory bodies, overseeing the preparation, submission, and maintenance of product dossiers. This role is critical for ensuring that all pharmaceutical products meet local regulatory requirements, adhere to international standards, and achieve timely market authorization. The specialist will work closely with cross‑functional teams, including Clinical Development, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. By providing expert guidance on regulatory policies, the specialist will help Pfizer maintain its reputation for compliance and excellence in the Eritrean market.
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Key Responsibilities
- Prepare, review, and submit regulatory dossiers for new drug applications, variations, and renewals in accordance with Eritrean Ministry of Health guidelines.
- Maintain up‑to‑date knowledge of local and international regulatory requirements, including WHO, ICH, and regional guidelines.
- Coordinate with internal stakeholders to gather necessary data, ensuring accuracy and completeness of submissions.
- Respond to queries from regulatory authorities, providing scientific and technical explanations as needed.
- Develop and implement regulatory strategies that support product lifecycle management and market expansion.
- Monitor changes in legislation and advise senior management on potential impacts to product pipelines.
- Assist in the preparation of labeling, packaging, and promotional materials to ensure compliance.
- Participate in audits and inspections, facilitating corrective actions and continuous improvement.
Required Skills
- Strong understanding of pharmaceutical regulatory frameworks and submission processes.
- Excellent written and verbal communication skills in English; proficiency in Arabic or Tigrinya is a plus.
- Analytical mindset with the ability to interpret complex scientific data.
- Detail‑oriented approach with strong organizational and project‑management abilities.
- Proficiency in regulatory software tools and Microsoft Office suite.
- Ability to work collaboratively across multidisciplinary teams.
Education
A minimum of a Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. Advanced degrees (MSc or PhD) or certifications in regulatory affairs are highly desirable and will be considered an asset.
Experience
Candidates should have 3 to 5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African markets. Experience with dossier preparation, submission, and interaction with health authorities is essential.
Salary
The position offers a competitive salary range of 150,000 to 250,000 SSP per month, commensurate with experience and qualifications. Additional performance‑based incentives may be provided.
Benefits
- Comprehensive health insurance covering employee and dependents.
- Retirement savings plan with employer contributions.
- Paid annual leave and public holidays in accordance with Eritrean labor law.
- Professional development allowance for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering Pfizer’s global regulatory standards and local compliance requirements.
- Continuous training modules on regulatory updates, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
- Mentorship opportunities with senior regulatory professionals across Pfizer’s global network.
Working Environment
Pfizer’s Asmara office provides a modern, collaborative workspace equipped with the latest technology to support regulatory activities. The culture emphasizes innovation, integrity, and a commitment to improving health outcomes. Employees enjoy a supportive environment that encourages knowledge sharing, professional growth, and work‑life balance.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining relevant 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 a virtual interview followed by an on‑site assessment.
Equal Opportunity Statement
Pfizer 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 any other protected characteristic. All qualified applicants will receive consideration for employment without regard to any such status.
