Regulatory Affairs Specialist Job Vacancy in Selibe Phikwe, Botswana – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer Botswana

Location: Selibe Phikwe, Botswana

Experience: 3-5 years

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 250,000 – 350,000 per annum

Vacancies:1

Company Overview

Pfizer Botswana is a leading global pharmaceutical company dedicated to improving health outcomes across the African continent. With a strong commitment to research, development, and responsible manufacturing, Pfizer Botswana operates state‑of‑the‑art facilities and collaborates with local health ministries, hospitals, and research institutions. The company’s presence in Botswana supports the nation’s vision for a robust healthcare ecosystem, creating career opportunities that contribute to the country’s economic growth. As part of Pfizer’s worldwide network, employees in Selibe Phikwe enjoy access to cutting‑edge technology, continuous professional development, and a culture that values innovation, integrity, and diversity. This role offers a unique chance to be part of a dynamic team that drives regulatory excellence and ensures that life‑saving medicines reach patients safely and efficiently. Botswana Jobs seekers looking for meaningful impact will find this position aligns with their aspirations for career advancement and societal contribution.

Job Overview

The Regulatory Affairs Specialist will serve as the primary liaison between Pfizer Botswana and national regulatory authorities, ensuring that all pharmaceutical products comply with local laws, guidelines, and international standards. This role involves preparing and submitting dossiers, managing product registrations, and providing strategic guidance on regulatory pathways for new and existing medicines. The specialist will work closely with cross‑functional teams, including Clinical Development, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. By maintaining up‑to‑date knowledge of evolving regulations, the specialist safeguards product integrity and accelerates market access, directly supporting Pfizer’s mission to deliver innovative therapies to patients in Botswana. For more information about career opportunities, visit https://botswanajobsearch.com/.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for product registration, variation, and renewal in accordance with Botswana Medicines Regulatory Authority (BMRA) requirements.
• Maintain comprehensive regulatory intelligence, monitoring changes in legislation, guidelines, and industry standards.
• Collaborate with R&D, Quality, and Commercial teams to develop regulatory strategies that support product lifecycle management.
• Act as the primary point of contact with BMRA, facilitating inspections, audits, and post‑approval commitments.
• Develop and maintain regulatory documentation, including standard operating procedures, risk assessments, and compliance reports.
• Provide regulatory guidance and training to internal stakeholders to ensure adherence to best practices.
• Support the preparation of labeling, packaging, and promotional materials to meet regulatory compliance.
• Participate in cross‑functional project teams to accelerate product launches and market entry.

Required Skills

• In‑depth knowledge of Botswana pharmaceutical regulations and international guidelines (ICH, WHO).
• Strong analytical and problem‑solving abilities with meticulous attention to detail.
• Excellent written and verbal communication skills for effective interaction with regulators and internal teams.
• Proficiency in regulatory submission software and Microsoft Office suite.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Team‑oriented mindset with the capacity to influence and negotiate across functions.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced certifications or a Master’s degree in Regulatory Affairs are highly desirable and will be considered an advantage.

Experience

Applicants should have 3 to 5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to the African regulatory environment. Experience with product submissions, label approvals, and post‑marketing surveillance is essential.

Salary

The compensation package ranges from SSP 250,000 to 350,000 annually, commensurate with experience and qualifications. The package includes performance‑based incentives, health insurance, and retirement benefits.

Benefits

• Comprehensive medical and dental coverage for employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid time off and parental leave.
• Employee assistance program and wellness initiatives.
• Opportunities for international assignments and career progression within Pfizer’s global network.

Training

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

Working Environment

Pfizer Botswana offers a collaborative, inclusive, and safety‑focused workplace. Employees work in modern office spaces equipped with advanced technology, fostering innovation and teamwork. The company promotes a healthy work‑life balance and encourages community involvement through corporate social responsibility initiatives.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their regulatory 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 interviews.

Equal Opportunity Statement

Pfizer Botswana 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. Botswana Jobs seekers are encouraged to apply.