Regulatory Affairs Specialist Job Vacancy in Lushoto, Tanzania – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: GlaxoSmithKline Tanzania

Location: Lushoto, 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: SSP 2,000,000 – 3,500,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline Tanzania (GSK Tanzania) is a leading global healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence in Tanzania for over two decades, GSK Tanzania operates state‑of‑the‑art manufacturing facilities, research laboratories, and a robust distribution network that reaches every corner of the country, from bustling Dar es Salaam to remote highland towns like Lushoto. The company’s mission is to innovate, develop, and deliver high‑quality medicines, vaccines, and consumer health products that address the most pressing health challenges in Tanzania. As part of its commitment to local talent, GSK Tanzania invests heavily in capacity building, community health programs, and sustainable business practices, making it a top employer for ambitious professionals seeking meaningful career opportunities in Tanzania. This role contributes directly to GSK’s vision of ensuring that safe, effective, and affordable medicines are available to all Tanzanians, reinforcing the company’s reputation as a trusted partner in the nation’s healthcare ecosystem.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that all GSK Tanzania products comply with local and international regulatory requirements. Reporting to the Head of Regulatory Affairs, the specialist will manage product registrations, maintain dossiers, and liaise with the Tanzania Food and Drugs Authority (TFDA) and other relevant bodies. This position offers a unique opportunity to work at the intersection of science, law, and business, influencing the timely launch of life‑saving medicines across the Tanzanian market. For more information, visit our careers page and discover how you can contribute to a healthier Tanzania.

Key Responsibilities

• Prepare, submit, and maintain product registration dossiers in compliance with TFDA guidelines.
• Monitor changes in local and international regulations and assess impact on existing and pipeline products.
• Collaborate with cross‑functional teams including R&D, Quality Assurance, and Marketing to ensure regulatory alignment throughout product lifecycle.
• Provide regulatory guidance and training to internal stakeholders to foster a culture of compliance.
• Manage timelines for regulatory submissions, ensuring on‑time approvals for product launches.
• Maintain accurate records of all regulatory activities and generate periodic compliance reports for senior management.

Required Skills

• In‑depth knowledge of Tanzanian pharmaceutical regulations and international standards such as ICH and WHO.
• 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.
• Strong interpersonal skills to build effective relationships with internal teams and external authorities.

Education

The ideal candidate holds a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Advanced certifications in regulatory affairs (e.g., RAC, RAPS) are highly desirable and will be considered an advantage during the selection process.

Experience

Applicants should have a minimum of three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with a focus on product registration and lifecycle management in Tanzania or comparable emerging markets.

Salary

GSK Tanzania offers a competitive salary range of SSP 2,000,000 to 3,500,000 per month, commensurate with experience and qualifications. The compensation package is designed to attract top talent and reflects the company’s commitment to rewarding performance and dedication.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid leave, including annual, sick, and parental leave.
• Performance‑based bonuses and annual salary reviews.
• Employee assistance program and wellness initiatives.

Training

• Continuous professional development through GSK’s global learning platform.
• Access to industry conferences, workshops, and certification courses.
• On‑the‑job mentorship from senior regulatory experts.
• Leadership development programs for high‑potential employees.

Working Environment

GSK Tanzania provides a modern, collaborative workplace that encourages innovation and teamwork. Employees benefit from a supportive culture that values diversity, inclusion, and work‑life balance. State‑of‑the‑art laboratories and office spaces are equipped with the latest technology, ensuring that staff can perform at their best while contributing to the company’s mission of improving health outcomes across Tanzania.

Application Process

Interested candidates are invited to submit their application through the online portal on our website. The application should include an up‑to‑date CV, a cover letter outlining relevant experience, and copies of academic certificates. Shortlisted applicants will be contacted for a series of interviews, which may include a technical assessment and a final interview with senior management.

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.