Senior Pharmaceutical Regulatory Affairs Specialist Job Vacancy in Blantyre, Malawi – Healthcare & Pharmaceuticals

Job Description

Position: Senior Pharmaceutical Regulatory Affairs Specialist

Company: Novartis Malawi

Location: Blantyre, Malawi

Experience: 7-10 years

Education: Master of Pharmacy or PhD in Regulatory Science

Employment Type: Full-time

Industry: Healthcare & Pharmaceuticals

Department: Regulatory Affairs

Salary: 1,200,000 – 1,800,000 SSP

Vacancies: 1

Company Overview

Novartis Malawi is a leading global healthcare organization dedicated to transforming medicine through innovative science and cutting-edge technology. As a key player in the regional pharmaceutical landscape, we focus on delivering life-changing therapies to patients facing complex medical conditions. Our mission is to reimagine medicine to improve and extend people’s lives. We operate with the highest standards of integrity, ensuring that every product reaching the market is safe, effective, and compliant with international health protocols. By fostering a culture of excellence and continuous learning, we provide a stable and rewarding environment for professionals seeking meaningful career opportunities in Malawi.

Job Overview

We are currently seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Specialist to lead our compliance initiatives within the Malawi market. This critical role involves navigating complex legal frameworks to ensure all pharmaceutical products meet the stringent requirements of local and international health authorities. The successful candidate will act as the primary liaison between the company and regulatory bodies, ensuring seamless product registration and lifecycle management. This is a premier job vacancy in Malawi for a professional who possesses deep technical knowledge and strategic thinking. For more information on global career paths, visit https://malawijobsearch.com.

Key Responsibilities

• Lead the preparation and submission of dossiers for new drug applications (NDAs) and variations to the Malawi Medicines Regulatory Authority (🇲🇲).
• Monitor changes in local and international pharmaceutical regulations to ensure continuous organizational compliance.
• Coordinate with the manufacturing and quality assurance teams to ensure all technical documentation is accurate and up-to-date.
• Manage the lifecycle of existing products, including renewals, labeling updates, and safety reporting.
• Represent the company in meetings with government officials and health regulatory agencies.
• Oversee the implementation of pharmacovigilance protocols to ensure patient safety and regulatory adherence.

Required Skills

• Expert-level knowledge of ICH (International Council for Harmonisation) guidelines and local regulatory frameworks.
• Exceptional technical writing skills for the preparation of complex regulatory dossiers.
• Strong analytical skills to interpret scientific data and regulatory requirements.
• Advanced stakeholder management and negotiation abilities.
• High level of attention to detail and organizational proficiency.

Education

A Master of Pharmacy, PhD in Regulatory Science, or a related pharmaceutical science degree is mandatory. Professional certification in Regulatory Affairs is highly preferred.

Experience

Candidates must demonstrate a minimum of 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 essential. This role offers significant employment in Malawi for seasoned experts.

Salary

The monthly salary for this position ranges from 1,200,000 to 1,800,000 SSP, depending on the candidate’s expertise and previous experience in the sector.

Benefits

• Comprehensive medical insurance coverage for the employee and immediate family.
• Performance-based annual bonuses and long-term incentive plans.
• Generous paid time off and parental leave policies.
• Subsidized wellness programs and health screenings.

Training

• Continuous professional development through international regulatory workshops.
• Access to advanced pharmaceutical science training modules.
• Leadership and strategic management training programs.

Working Environment

The working environment is professional, collaborative, and highly structured. While the role is primarily office-based in Blantyre, it requires occasional travel to regulatory offices and manufacturing sites. We prioritize a healthy work-life balance and provide modern facilities to support your productivity. Explore more international roles at https://mauritiusjobsearch.com/job-vacancy-mauritius/.

Application Process

Interested candidates should submit their updated CV and a cover letter detailing their regulatory experience through our official recruitment portal. We are looking for individuals who are passionate about healthcare and innovation. For more diverse job opportunities across the continent, please visit https://angolajobsearch.com/.

Equal Opportunity Statement

Novartis Malawi 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, without regard to race, religion, color, national origin, gender, sexual orientation, age, or disability status.