Regulatory Compliance Officer Job Vacancy in Vilankulo, Mozambique – Pharmaceuticals

Job Description

Position: Regulatory Compliance Officer

Company: GlaxoSmithKline (GSK) Mozambique

Location: Vilankulo, Mozambique

Experience: 5+ years in regulatory affairs within pharmaceutical industry

Education: Bachelor’s degree in Pharmacy, Chemistry, or related field; Master’s preferred

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory & Compliance

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

Vacancies:1

Company Overview

GlaxoSmithKline (GSK) Mozambique is a leading global healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence in Mozambique, GSK operates state‑of‑the‑art manufacturing facilities, research labs, and a robust distribution network that serves the entire Southern African region. The company’s commitment to innovation, quality, and ethical standards makes it a top employer for professionals seeking meaningful impact. As part of GSK’s mission to develop affordable medicines and vaccines, the Mozambique branch plays a pivotal role in ensuring product safety, regulatory compliance, and market access. This environment offers unparalleled career growth, exposure to international best practices, and the chance to contribute to life‑saving health solutions, making it an attractive destination for ambitious talent looking for Mozambique Jobs that truly matter.

Job Overview

The Regulatory Compliance Officer will lead the development, implementation, and maintenance of regulatory strategies that ensure all GSK products meet local and international standards. Reporting to the Head of Regulatory Affairs, the officer will collaborate with cross‑functional teams, including Quality Assurance, Manufacturing, and Marketing, to navigate complex regulatory landscapes. This role is essential for safeguarding product integrity, facilitating market entry, and supporting GSK’s reputation for excellence. Candidates will engage with Mozambican health authorities, international agencies, and internal stakeholders to drive compliance initiatives. For more information about GSK’s commitment to career development, visit Mozambique Job Search.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations, variations, and renewals in Mozambique.
• Maintain up‑to‑date knowledge of local health authority guidelines, ICH, WHO, and EU regulations.
• Prepare, review, and submit dossiers, including CTDs, INDs, and marketing authorisation applications.
• Coordinate internal audits and inspections, ensuring corrective actions are implemented promptly.
• Serve as the primary liaison with the Instituto Nacional de Saúde (INS) and other regulatory bodies.
• Provide regulatory guidance to R&D, manufacturing, and commercial teams throughout product lifecycle.
• Monitor post‑marketing compliance, adverse event reporting, and product recalls.
• Lead training sessions on regulatory requirements for staff across departments.
• Maintain comprehensive regulatory documentation and databases in line with GSK standards.
• Support continuous improvement initiatives to streamline regulatory processes.

Required Skills

• In‑depth understanding of pharmaceutical regulatory frameworks in Mozambique and internationally.
• Excellent written and verbal communication skills in English and Portuguese.
• Strong analytical and problem‑solving abilities with attention to detail.
• Proficiency in regulatory submission software and document management systems.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Negotiation and stakeholder management skills.
• High ethical standards and commitment to compliance.

Education

A minimum of a Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. A Master’s degree or professional certification (e.g., RAPS, RAC) is highly desirable and will be considered an advantage during the selection process.

Experience

Applicants must have at least five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local Mozambican and international regulatory submissions. Experience in a multinational environment and familiarity with GSK’s internal processes are advantageous.

Salary

The position offers a competitive salary range of SSP 250,000 to 350,000 per month, commensurate with experience and qualifications. Performance‑based bonuses and annual salary reviews are part of GSK’s compensation framework.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Generous paid time off, including vacation, sick leave, and public holidays.
• Professional development allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.
• Relocation assistance for candidates moving to Vilankulo.

Training

• Onboarding program covering GSK’s compliance culture and regulatory processes.
• Continuous learning modules on global regulatory updates and best practices.
• Mentorship opportunities with senior regulatory leaders.
• Access to GSK’s internal e‑learning platform for skill enhancement.

Working Environment

GSK Mozambique offers a collaborative, inclusive, and safety‑first workplace located in the vibrant coastal city of Vilankulo. Employees benefit from modern office facilities, flexible working arrangements, and a culture that encourages innovation and teamwork. The company’s commitment to sustainability and community engagement creates a rewarding atmosphere where professionals can thrive while contributing to the health of the nation.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the GSK careers portal. Applications will be reviewed on a rolling basis, and shortlisted applicants will be contacted for a virtual interview followed by an on‑site assessment in Vilankulo.

Equal Opportunity Statement

GlaxoSmithKline (GSK) Mozambique 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. Our hiring practices reflect our dedication to fairness and meritocracy, ensuring that every candidate has an equal chance to succeed.