Senior Pharmaceutical Regulatory Affairs Specialist Job Vacancy in Dedza, Malawi – Healthcare & Life Sciences

Job Description

Position: Senior Pharmaceutical Regulatory Affairs Specialist

Company: Sanofi Malawi

Location: Dedza, Malawi

Experience: 5-7 years

Education: Master of Science in Pharmacology or Pharmacy

Employment Type: Full-time

Industry: Healthcare & Life Sciences

Department: Regulatory Affairs

Salary: 850,000 SSP – 1,200,000 SSP

Vacancies: 1

Company Overview

Sanofi is a global leader in healthcare, dedicated to transforming the science to improve people’s lives. As a major player in the pharmaceutical industry, our mission is to pursue innovative solutions for patients facing serious diseases. In Malawi, we are committed to improving access to essential medicines and ensuring that high-quality healthcare products reach the communities that need them most. We pride ourselves on a culture of scientific excellence, integrity, and patient-centricity. By joining our team, you become part of a global network of professionals working toward a healthier future for all. We offer a dynamic environment where innovation meets purpose, providing exceptional career opportunities in Malawi for those passionate about medical advancement and public health safety.

Job Overview

We are seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Specialist to lead our regulatory compliance efforts in the region. This role is critical in ensuring that all our pharmaceutical products meet the stringent requirements set by the Malawi Pharmacy and Poisons Board and other regional health authorities. The successful candidate will act as the primary liaison between the company and regulatory bodies, managing the lifecycle of product registrations, variations, and renewals. This position requires a deep understanding of local and international pharmaceutical regulations to ensure seamless market access for our life-saving treatments. If you are looking for meaningful employment in Malawi within the life sciences sector, this role offers a platform to influence healthcare outcomes at scale. For more information on local openings, visit https://malawijobsearch.com.

Key Responsibilities

• Lead the preparation and submission of dossiers for new product registrations and variations.
• Maintain up-to-date knowledge of evolving pharmaceutical laws and regulatory guidelines in Malawi.
• Coordinate with the supply chain and quality assurance teams to ensure all labeling and packaging meet regulatory standards.
• Manage the lifecycle of existing product licenses, including timely renewals and post-approval changes.
• Represent the company during inspections and audits conducted by health authorities.
• Monitor competitor regulatory activities and provide strategic insights to the marketing team.

Required Skills

• Expertise in CTD (Common Technical Document) formats and regulatory submission processes.
• Strong analytical skills with the ability to interpret complex scientific and legal documentation.
• Exceptional communication skills for interacting with government officials and internal stakeholders.
• High attention to detail regarding compliance and documentation accuracy.
• Project management skills to handle multiple registration timelines simultaneously.

Education

A Master of Science in Pharmacology, Pharmaceutical Sciences, or a related medical field is required. A Bachelor of Pharmacy (BPharm) with significant regulatory experience may also be considered.

Experience

Candidates must possess a minimum of 5 to 7 years of experience in pharmaceutical regulatory affairs, preferably within a multinational pharmaceutical environment. Proven track record of successful product registrations in the African market is highly desirable.

Salary

The monthly salary for this position ranges from 850,000 SSP to 1,200,000 SSP, depending on the candidate’s expertise and qualifications.

Benefits

• Comprehensive health insurance coverage for the employee and dependents.
• Performance-based annual bonuses.
• Professional development and certification reimbursement.
• Commuter allowance and wellness programs.

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Training

• Continuous professional development in global regulatory standards.
• Internal leadership and management training programs.
• Specialized workshops on pharmaceutical law and compliance.

Working Environment

The working environment is professional, collaborative, and highly structured. While the role is primarily office-based in Dedza, occasional travel to regulatory offices and manufacturing sites may be required. We foster a culture of continuous learning and scientific rigor.

Application Process

Interested candidates should submit their updated CV and a cover letter detailing their regulatory experience. Please ensure all documentation is accurate and reflects your current professional standing. We are currently hiring in Malawi and look forward to reviewing your application.

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Equal Opportunity Statement

Sanofi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business needs.