Job Description
Position:Regulatory Compliance Officer
Company:GlaxoSmithKline Tanzania
Location:Tunduma, Tanzania
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:2,000,000 – 3,500,000 SSP per month
Vacancies:1
Company Overview
GlaxoSmithKline Tanzania (GSK Tanzania) is a leading multinational pharmaceutical company dedicated to improving health outcomes across the African continent. With a strong focus on research, development, and responsible marketing, GSK Tanzania operates state‑of‑the‑art manufacturing facilities, distribution networks, and a robust regulatory framework that ensures the safety and efficacy of its products. As part of the global GSK family, the Tanzanian branch adheres to the highest standards of corporate governance, sustainability, and community engagement, making it an attractive employer for professionals seeking meaningful impact in the healthcare sector. The company’s commitment to innovation, ethical practices, and employee development creates a dynamic environment where talent thrives and contributes to the broader goal of enhancing the health of Tanzanians.
Job Overview
The Regulatory Compliance Officer will play a pivotal role in ensuring that all GSK Tanzania products, processes, and promotional activities comply with local and international regulatory requirements. Reporting to the Head of Regulatory Affairs, the incumbent will collaborate closely with cross‑functional teams, including Quality Assurance, Clinical Development, Marketing, and Supply Chain, to embed compliance into every stage of the product lifecycle. This position offers a unique opportunity to influence regulatory strategy, support product registrations, and safeguard the company’s reputation in a rapidly evolving pharmaceutical landscape. The role is central to GSK’s mission of delivering safe, effective, and affordable medicines to patients in Tanzania and aligns with the broader objectives of career opportunities in Tanzania and employment in Tanzania.
Key Responsibilities
- Monitor and interpret Tanzanian Medicines and Medical Devices Authority (TMDA) regulations, as well as relevant international guidelines (e.g., WHO, ICH).
- Prepare, review, and submit regulatory dossiers for new product registrations, variations, and renewals.
- Conduct internal audits and risk assessments to ensure ongoing compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards.
- Provide regulatory guidance to marketing and sales teams on promotional material approvals and claims substantiation.
- Maintain a comprehensive regulatory intelligence database and disseminate updates to relevant stakeholders.
- Collaborate with external consultants, legal counsel, and TMDA officials to resolve compliance issues promptly.
- Support the development and implementation of standard operating procedures (SOPs) related to regulatory affairs.
- Participate in cross‑functional project teams to ensure regulatory considerations are integrated early in product development.
- Prepare periodic compliance reports for senior management and external auditors.
- Assist in training programs to raise awareness of regulatory requirements across the organization.
Required Skills
- In‑depth knowledge of Tanzanian pharmaceutical regulations and international regulatory frameworks.
- Strong analytical and problem‑solving abilities with attention to detail.
- Excellent written and verbal communication skills in English and Swahili.
- Proficiency in regulatory submission software and Microsoft Office Suite.
- Ability to work independently and manage multiple projects under tight deadlines.
- Negotiation and stakeholder management skills for effective liaison with authorities.
Education
A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. A Master’s degree or professional certification (e.g., RAC, RAPS) is advantageous but not mandatory.
Experience
Applicants must have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to product registration and compliance monitoring in Tanzania or comparable emerging markets.
Salary
The position offers a competitive salary range of 2,000,000 to 3,500,000 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.
- Annual leave and paid public holidays in accordance with Tanzanian labor law.
- Professional development budget for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering GSK’s global compliance standards and local regulatory landscape.
- Continuous learning modules on regulatory updates, GMP, and GCP.
- Mentorship opportunities with senior regulatory leaders.
Working Environment
GSK Tanzania provides a collaborative, inclusive, and safety‑first workplace. The office is located in Tunduma’s industrial zone, offering modern facilities, secure access, and a supportive team culture that encourages innovation and professional growth. Employees benefit from flexible working arrangements where permissible, fostering work‑life balance while maintaining high performance standards.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their suitability for the role via the online portal on Tanzania Job Search. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview. The recruitment process includes a technical assessment, competency interview, and a final discussion with the Head of Regulatory Affairs.
Equal Opportunity Statement
GlaxoSmithKline Tanzania 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, or sexual orientation. All qualified applicants will receive consideration for employment without discrimination.