Regulatory Affairs Specialist Job Vacancy in Maun, Botswana – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer Botswana

Location: Maun, Botswana

Experience: 3-5 years in pharmaceutical regulatory affairs

Education: Bachelor’s degree in Pharmacy, Life Sciences or related field

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 120,000 – 150,000 per annum

Vacancies:1

Company Overview

Pfizer Botswana is a leading global pharmaceutical company dedicated to improving health outcomes across Africa. Operating from a modern facility in Maun, the company supports the national health agenda through the supply of essential medicines, vaccines, and innovative therapies. Pfizer’s commitment to quality, ethical standards, and community engagement makes it a trusted partner for the Botswana Medicines Regulatory Authority and local health ministries.

The Maun office serves as a regional hub for regulatory activities, market access, and stakeholder collaboration. Employees benefit from a culture that values scientific excellence, continuous learning, and a patient‑centric approach. By joining Pfizer Botswana, you become part of a diverse team that drives health innovation while contributing to the country’s Vision 2036 goals.

Job Overview

The Regulatory Affairs Specialist will lead the preparation, submission, and maintenance of product dossiers for medicines and vaccines marketed in Botswana and neighboring regions. This role ensures compliance with BMRA regulations, monitors regulatory changes, and collaborates with cross‑functional teams to align strategies with business objectives. The position offers a unique chance to influence product life cycles, support market entry, and safeguard patient safety.

For more information about career opportunities in Botswana, visit our partner portal at https://botswanajobsearch.com. Additional resources for regional job seekers can be found at https://www.southsudanjobsearch.com/.

Key Responsibilities

• Prepare, review, and submit regulatory applications, variations, and renewals to the BMRA.
• Develop regulatory strategies that align with product development timelines and market access goals.
• Collaborate with Clinical, Quality, and Manufacturing teams to ensure data integrity.
• Monitor local and international regulatory changes and provide proactive guidance.
• Maintain accurate regulatory files, correspondence, and audit trails.
• Represent Pfizer Botswana in meetings with health authorities and industry groups.
• Support post‑marketing surveillance, including adverse event reporting and labeling updates.
• Prepare regulatory intelligence reports and risk assessments.

Required Skills

• Strong knowledge of BMRA regulations, ICH guidelines, and global regulatory frameworks.
• Excellent analytical, problem‑solving, and attention‑to‑detail abilities.
• Effective written and verbal communication for dossier preparation and authority interaction.
• Proficiency with regulatory software tools and Microsoft Office.
• Ability to manage multiple projects and meet strict deadlines.
• Team‑oriented mindset with experience in cross‑functional environments.
• High ethical standards and commitment to patient safety.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced degrees (MSc, PhD) or certifications such as RAC are highly desirable.

Experience

Minimum of three to five years of hands‑on regulatory affairs experience in the pharmaceutical industry, preferably with product submissions in African markets.

Salary

The compensation package ranges from SSP 120,000 to SSP 150,000 per annum, commensurate with experience and qualifications, and includes performance‑based incentives.

Benefits

• Comprehensive medical and dental coverage for employee and dependents.
• Retirement savings plan with employer matching contributions.
• Annual leave, sick leave, and paid public holidays as per Botswana law.
• Employee assistance program and wellness initiatives.
• Opportunities for international assignments and cross‑border projects.
• Transportation allowance for commuting to the Maun office.

Training

• On‑boarding program covering Pfizer’s global regulatory policies and local compliance.
• Continuous professional development through workshops, conferences, and e‑learning.
• Mentorship from senior regulatory leaders within the African region.
• Access to Pfizer’s internal knowledge hub for regulatory intelligence.

Working Environment

Pfizer Botswana offers a modern office in Maun with collaborative workspaces, secure document management, and flexible working arrangements. The culture promotes work‑life balance, inclusivity, and a supportive atmosphere where innovation thrives.

Application Process

Submit your application through the Pfizer Careers portal, including a resume, cover letter, and copies of relevant certifications. Shortlisted candidates will be invited to a virtual interview followed by an on‑site assessment at the Maun office. The recruitment timeline is typically four to six weeks.

Equal Opportunity Statement

Pfizer Botswana is an equal opportunity employer. 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.