Regulatory Affairs Specialist Job Vacancy in Lichinga, Mozambique – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer Inc.

Location: Lichinga, Mozambique

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: 150,000 – 250,000 SSP per month

Vacancies:1

Company Overview

Pfizer Inc. is a world‑leading biopharmaceutical company dedicated to improving health outcomes across the globe. With a strong presence in Africa, Pfizer operates in Mozambique through a regional hub that supports local manufacturing, distribution, and research initiatives. The company’s commitment to innovation, quality, and community health aligns with Mozambique’s growing demand for advanced medical solutions. As part of its strategic expansion, Pfizer is investing in talent that can navigate complex regulatory landscapes, ensuring that life‑saving medicines reach patients safely and efficiently. This role contributes directly to the company’s mission of delivering breakthrough therapies while supporting local economic development and creating sustainable career pathways for Mozambican professionals.

Job Overview

The Regulatory Affairs Specialist will serve as the primary liaison between Pfizer’s global regulatory teams and Mozambique’s health authorities. You will be responsible for preparing, submitting, and maintaining regulatory dossiers for new and existing pharmaceutical products, ensuring compliance with local and international standards. This position plays a critical role in accelerating product approvals, safeguarding public health, and supporting the launch of innovative therapies in the Mozambican market. For more information, visit Mozambique Job Search. This opportunity is a key component of our broader effort to create high‑impact Mozambique Jobs and expand career opportunities for qualified professionals.

Key Responsibilities

• Prepare and submit registration dossiers for new drug applications, variations, and renewals in compliance with ANVISA Mozambique guidelines.
• Maintain up‑to‑date regulatory intelligence on changes in legislation, guidelines, and industry standards.
• Coordinate cross‑functional teams—including Clinical, Quality, Manufacturing, and Marketing—to gather required documentation.
• Develop and review labeling, packaging, and promotional materials to ensure regulatory conformity.
• Act as the primary point of contact with the Ministry of Health and other regulatory bodies for queries and inspections.
• Monitor post‑approval commitments, adverse event reporting, and product lifecycle management.
• Provide regulatory strategy input for product pipeline planning and market entry.
• Support internal audits and inspections by preparing required documentation and evidence.

Required Skills

• In‑depth knowledge of Mozambican pharmaceutical regulations and ICH guidelines.
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills in English and Portuguese.
• Proficiency in regulatory submission software and document management systems.
• Ability to work collaboratively across multicultural teams and manage multiple priorities.
• Project management experience with a focus on timelines and deliverables.

Education

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 (e.g., RAC) is highly desirable and will be considered an advantage during the selection process.

Experience

Candidates must have a minimum of three to five years of hands‑on experience in regulatory affairs within the pharmaceutical sector, preferably with exposure to both local and international submission processes. Experience working with health authorities in Sub‑Saharan Africa is a strong plus.

Salary

The compensation package ranges from 150,000 to 250,000 SSP per month, commensurate with experience and qualifications. The package includes performance‑based incentives, health insurance, and a pension contribution scheme.

Benefits

• Comprehensive medical and dental coverage for employee and dependents.
• Retirement savings plan with company matching.
• Generous paid time off and national holidays.
• Employee assistance program and wellness initiatives.
• Opportunities for international mobility and career advancement.

Training

• On‑boarding program covering Pfizer’s compliance framework and local regulatory environment.
• Continuous professional development courses, including regulatory updates and leadership workshops.
• Access to Pfizer’s global learning platform for certifications and skill enhancement.

Working Environment

Pfizer offers a dynamic, inclusive, and collaborative workplace where innovation thrives. Our Lichinga office provides modern facilities, flexible working arrangements, and a culture that values diversity, integrity, and scientific excellence. Employees are encouraged to share ideas, engage in community outreach, and contribute to sustainable health initiatives across Mozambique.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their 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 in Lichinga.

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 and be part of a team that is shaping the future of healthcare in Mozambique and beyond.