Senior Pharmaceutical Regulatory Affairs Manager Job Vacancy in Mangochi, Malawi – Healthcare & Pharmaceuticals

Job Description

Position: Senior Pharmaceutical Regulatory Affairs Manager

Company: Roche Malawi

Location: Mangochi, Malawi

Experience: 8-10 years

Education: Master of Pharmacy or PhD in Pharmacology

Employment Type: Full-time

Industry: Healthcare & Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 4,500,000 – SSP 7,500,000

Vacancies:1

Company Overview

Roche is a global leader in healthcare, dedicated to improving lives through cutting-edge pharmaceuticals and diagnostics. In Malawi, we are expanding our footprint to ensure that life-saving medications reach the populations that need them most. Our mission is to combine biology and technology to deliver personalized medicine that transforms patient outcomes. As we grow our presence in the region, we are looking for exceptional talent to join our mission-driven team. We pride ourselves on a culture of innovation, integrity, and deep respect for the communities we serve. By joining Roche, you are not just taking a job; you are embarking on a journey to redefine the future of medicine in Africa. We offer a dynamic environment where scientific excellence meets operational efficiency, providing numerous career opportunities in Malawi for professionals who want to make a tangible impact on public health.

For more information about our global initiatives, please visit https://malawijobsearch.com.

Job Overview

The Senior Pharmaceutical Regulatory Affairs Manager will play a critical role in navigating the complex legal and regulatory landscape of the Malawian healthcare sector. This position is responsible for ensuring that all Roche products comply with national regulations and international standards. You will act as the primary liaison between the company and the Pharmacy and Medicines Regulatory Authority (PMRA). This role requires a strategic thinker who can manage product registrations, clinical trial approvals, and post-market surveillance with precision. As we continue our hiring in Malawi, this leadership role is designed for a professional who can harmonize global regulatory strategies with local requirements to accelerate market access. You will lead a specialized team to ensure that our pipeline of innovative therapies moves seamlessly from development to the patient. This is a high-stakes role that demands meticulous attention to detail and a deep understanding of pharmaceutical law.

Key Responsibilities

• Lead the end-to-end registration process for new pharmaceutical products and medical devices.
• Maintain proactive relationships with the Pharmacy and Medicines Regulatory Authority (PMRA) and other government bodies.
• Develop and implement robust regulatory strategies to support product launches and lifecycle management.
• Monitor changes in local and international pharmaceutical legislation to ensure continuous compliance.
• Oversee the preparation and submission of technical dossiers, including CMC and clinical data.
• Manage post-market surveillance activities and report adverse events in accordance with local laws.
• Provide expert regulatory guidance to the marketing, supply chain, and medical affairs departments.
• Conduct regular internal audits to ensure all regulatory documentation is accurate and up-to-date.

Required Skills

• Expert knowledge of Malawian pharmaceutical laws and international regulatory frameworks (EMA/FDA).
• Proven ability to manage complex technical documentation and dossier submissions.
• Exceptional negotiation and communication skills for interacting with government officials.
• Strong analytical thinking and problem-solving capabilities in high-pressure environments.
• Advanced project management skills to handle multiple product lifecycles simultaneously.
• High level of integrity and commitment to ethical pharmaceutical practices.

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Education

Candidates must possess a Master of Pharmacy, a PhD in Pharmacology, or a related advanced scientific degree. A professional certification in Regulatory Affairs is highly preferred and will be considered an advantage during the selection process.

Experience

A minimum of 8 to 10 years of progressive experience in pharmaceutical regulatory affairs is required. At least 4 years of this experience must be in a senior or leadership capacity, preferably within a multinational pharmaceutical corporation. Proven track record of successful product registrations in the Southern African region is essential.

Salary

The monthly salary for this position ranges from SSP 4,500,000 to SSP 7,500,000, depending on the candidate’s expertise and previous experience. This is a competitive package designed to attract the highest caliber of talent in the industry.

Benefits

• Comprehensive health and dental insurance coverage.
• Performance-based annual bonuses.
• Generous pension scheme and retirement planning support.
• Company vehicle and fuel allowance for official duties.
• Relocation assistance for qualified candidates moving to Mangochi.
• Access to global professional development networks.

Training

• Advanced regulatory intelligence workshops.
• Leadership and management training programs.
• Continuous medical education (CME) support.
• Specialized training on new digital regulatory submission tools.

Working Environment

This role is based in Mangochi, offering a unique blend of professional challenge and a serene working environment. While much of the work is office-based, you will frequently interact with healthcare facilities, government offices, and distribution centers. We promote a healthy work-life balance and provide the tools necessary for both office and field-based success. This job vacancy in Malawi offers a stable and professional atmosphere where scientific rigor is celebrated.

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Application Process

Interested candidates should submit their updated CV and a detailed cover letter outlining their regulatory achievements. Applications will be reviewed on a rolling basis. Only shortlisted candidates will be contacted for an initial interview. We encourage all qualified individuals to apply for this employment in Malawi.

Equal Opportunity Statement

Roche is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, or any other basis covered by law. We believe that diverse teams drive innovation and better serve our patients.