Regulatory Affairs Specialist Job Vacancy in Chikwawa, Malawi – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer Malawi

Location: Chikwawa, Malawi

Experience: 3-5 years of regulatory affairs experience in the pharmaceutical sector

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 1,200,000 – SSP 1,800,000 per annum

Vacancies:1

Company Overview

Pfizer Malawi is a leading global biopharmaceutical company dedicated to improving health outcomes across the continent. With a strong presence in Malawi for over two decades, Pfizer combines cutting‑edge research, robust manufacturing capabilities, and a deep commitment to local community development. The company’s portfolio includes vaccines, oncology therapies, and essential medicines that address the most pressing health challenges in the region. As part of its mission to deliver innovative health solutions, Pfizer Malawi invests heavily in talent development, regulatory excellence, and sustainable practices, making it an attractive employer for professionals seeking meaningful impact. Join a dynamic team that values scientific rigor, ethical standards, and collaborative spirit while contributing to the growth of the pharmaceutical sector in Malawi. This role offers a unique opportunity to be at the forefront of regulatory strategy, ensuring that life‑saving products reach patients safely and efficiently.

Job Overview

The Regulatory Affairs Specialist will support Pfizer Malawi’s product registration, compliance, and post‑marketing surveillance activities. Working closely with cross‑functional teams, the specialist ensures that all pharmaceutical products meet local and international regulatory requirements. This position plays a pivotal role in preparing dossiers, liaising with the Malawi Pharmacy and Medicines Regulatory Authority (PMRA), and monitoring changes in legislation that affect product lifecycle. The role contributes to the company’s reputation for compliance excellence and supports the broader goal of expanding access to high‑quality medicines. For more information about Pfizer’s commitment to health innovation, visit https://malawijobsearch.com/.

Key Responsibilities

• Prepare and submit regulatory dossiers for new product registrations, variations, and renewals in accordance with PMRA guidelines.
• Maintain and update the regulatory database, ensuring all documentation is current and audit‑ready.
• Monitor and interpret local and international regulatory changes, advising internal stakeholders on impact and required actions.
• Coordinate with Quality Assurance, Clinical, and Manufacturing teams to gather necessary data for submissions.
• Facilitate communication with regulatory authorities, responding to queries and providing timely clarifications.
• Support post‑marketing surveillance activities, including adverse event reporting and product labeling updates.
• Develop and deliver regulatory training sessions for staff to promote compliance awareness.

Required Skills

• In‑depth knowledge of Malawi’s pharmaceutical regulatory framework and ICH guidelines.
• Strong analytical and documentation skills with attention to detail.
• Excellent written and verbal communication abilities.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Ability to work collaboratively across multidisciplinary teams.
• Problem‑solving mindset and proactive approach to regulatory challenges.

Education

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

Experience

Applicants must have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to product registration in African markets. Experience interacting with the PMRA or similar regulatory bodies is essential.

Salary

The annual salary range for this position is SSP 1,200,000 to SSP 1,800,000, commensurate with experience and qualifications. The package includes performance‑based incentives and statutory benefits.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Paid annual leave and sick leave in line with Malawi labour law.
• Professional development allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• Onboarding program covering Pfizer’s compliance standards and regulatory processes.
• Continuous learning opportunities through internal e‑learning platforms.
• Access to industry workshops, webinars, and external regulatory courses.

Working Environment

Pfizer Malawi offers a modern office environment equipped with state‑of‑the‑art technology, fostering collaboration and innovation. The company promotes a culture of safety, diversity, and inclusion, encouraging employees to share ideas and grow professionally.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining relevant 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 Malawi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, disability, or sexual orientation.