Regulatory Affairs Specialist Job Vacancy in Kasane, Botswana – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Novartis Botswana

Location: Kasane, Botswana

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: SSP 250,000 – SSP 350,000 per annum

Vacancies:1

Company Overview

Novartis Botswana is a leading global pharmaceutical company dedicated to improving health outcomes through innovative medicines and vaccines. With a strong presence across Africa, Novartis brings cutting‑edge research, development, and manufacturing capabilities to the region, fostering local talent and contributing to the national healthcare ecosystem. As part of its commitment to excellence, Novartis Botswana operates from state‑of‑the‑art facilities and collaborates closely with regulatory bodies, healthcare providers, and research institutions to ensure the highest standards of product safety and efficacy.

Located in the vibrant border town of Kasane, the company benefits from strategic proximity to regional markets and transport corridors, enabling efficient distribution of life‑saving therapies throughout Southern Africa. Novartis Botswana offers a dynamic work environment where employees are encouraged to innovate, grow, and make a tangible impact on the health of communities. This role presents an exciting opportunity for professionals seeking to advance their careers in a globally recognized organization while contributing to Botswana’s growing pharmaceutical sector.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that all Novartis products comply with local and international regulatory requirements. You will act as the primary liaison between Novartis Botswana and the Botswana Medicines Regulatory Authority (BMRA), preparing and submitting dossiers, managing product registrations, and providing strategic guidance on regulatory strategies. This position is essential for maintaining product integrity, facilitating market access, and supporting the company’s mission to deliver innovative therapies to patients across Botswana and the wider region.

For more information about Novartis Botswana and its commitment to health innovation, visit the official website at https://botswanajobsearch.com/. This role is a key component of our broader effort to attract top talent and expand career opportunities in Botswana, reinforcing our status as an employer of choice in the pharmaceutical industry.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications, variations, and renewals in compliance with BMRA guidelines.
• Maintain up‑to‑date knowledge of local and international regulatory frameworks, including ICH, WHO, and regional guidelines.
• Coordinate with cross‑functional teams—clinical, quality, manufacturing, and marketing—to gather required documentation and ensure alignment on regulatory strategies.
• Serve as the primary point of contact with the BMRA, responding to queries, facilitating inspections, and managing post‑approval commitments.
• Develop and implement regulatory risk assessments, ensuring proactive mitigation of potential compliance issues.
• Monitor and interpret changes in regulatory policies, providing timely updates and recommendations to senior management.
• Support product labeling, packaging, and advertising compliance to guarantee accurate and lawful communication of product information.

Required Skills

• Strong understanding of pharmaceutical regulatory processes and submission requirements.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Proficiency in preparing technical documents, including CTDs, INDs, and NDA submissions.
• Analytical mindset with strong problem‑solving abilities and attention to detail.
• Ability to work collaboratively across multidisciplinary teams and manage multiple projects simultaneously.
• Familiarity with electronic submission portals and regulatory information management systems.

Education

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Candidates holding a Master’s degree or professional certifications such as RAC (Regulatory Affairs Certification) are highly preferred, reflecting a commitment to continued professional development.

Experience

Applicants should possess 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local Botswana regulations and international guidelines. Experience in product registration, lifecycle management, and interaction with health authorities is essential.

Salary

The position offers a competitive salary range of SSP 250,000 to SSP 350,000 per annum, commensurate with experience and qualifications. Performance‑based incentives and annual reviews are part of the compensation package.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid leave, including annual, sick, and parental leave.
• Employee assistance program and wellness initiatives.
• Opportunities for international assignments and career progression within Novartis.

Training

• On‑the‑job regulatory training and mentorship programs.
• Access to Novartis University for continuous learning and professional certifications.
• Workshops on emerging regulatory trends and compliance technologies.
• Support for attending industry conferences and seminars.

Working Environment

Novartis Botswana fosters an inclusive, collaborative, and innovative workplace culture. Employees benefit from modern office facilities, flexible working arrangements, and a supportive leadership team that values diversity and encourages open communication. The Kasane location offers a unique blend of natural beauty and strategic connectivity, making it an inspiring place to work and live.

Application Process

Interested candidates should submit their application through the Novartis Careers portal, attaching a tailored CV and a cover letter outlining relevant experience and motivation for the role. Applications will be reviewed on a rolling basis, and shortlisted candidates will be invited for a virtual interview followed by an on‑site assessment at our Kasane office.

Equal Opportunity Statement

Novartis 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. We encourage qualified individuals from all backgrounds to apply and join our mission to improve health worldwide.