Pharmaceutical Regulatory Affairs Manager Job Vacancy in Gitarama, Rwanda – Healthcare & Regulatory Compliance

Job Description

Position: Pharmaceutical Regulatory Affairs Manager

Company: Novartis Rwanda

Location: Gitarama, Rwanda

Experience: Minimum 7 years in pharmaceutical regulatory affairs, with at least 3 years in a managerial role within Sub-Saharan Africa

Education: Master’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or related field. Additional certification in Regulatory Affairs (RAC) preferred

Employment Type: Full-time

Industry: Healthcare & Pharmaceutical

Department: Regulatory Affairs & Compliance

Vacancies:1

Company Overview

Novartis Rwanda is a leading global medicines company operating at the forefront of healthcare innovation in Rwanda. We use innovative science and digital technologies to create transformative treatments in areas of great medical need. Our mission is to reimagine medicine to improve and extend people’s lives, and we are committed to bringing life-saving and life-enhancing pharmaceuticals to the Rwandan population. As part of our expansion in East Africa, we are establishing a robust regulatory affairs hub in Gitarama to ensure compliance with Rwanda Food and Drugs Authority (FDA) regulations and facilitate timely access to innovative medicines. We offer exceptional Career Opportunities in Rwanda for professionals dedicated to advancing public health through regulatory excellence.

Job Overview

We are seeking an experienced Pharmaceutical Regulatory Affairs Manager to lead our regulatory strategy and submissions in Rwanda. This senior role is critical for ensuring all Novartis products meet local regulatory requirements for registration, licensing, and post-marketing surveillance. The successful candidate will serve as the primary liaison with the Rwanda FDA and other health authorities, managing the entire product lifecycle from clinical trial applications to market authorization and renewals. This position represents a unique Job Vacancy in Rwanda for regulatory professionals seeking to impact healthcare delivery at a national level. You will join a dynamic team committed to bringing innovative therapies to patients while maintaining the highest standards of regulatory compliance. For more Jobs in Rwanda across various sectors, visit https://rwandajobsearch.com.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for new product registrations, line extensions, and variations in alignment with Rwanda FDA requirements
• Prepare, compile, and submit high-quality regulatory dossiers (CTD format) for marketing authorization applications, renewals, and post-approval changes
• Serve as the primary regulatory contact for the Rwanda FDA, managing all communications, queries, and inspections throughout the review process
• Monitor and interpret evolving regulatory guidelines, legislation, and technical requirements issued by Rwanda FDA and other relevant East African Community (EAC) agencies
• Coordinate with global regulatory teams to ensure alignment of local submissions with international standards and company policies
• Manage regulatory aspects of clinical trial applications, including protocol submissions, amendments, and safety reporting to local ethics committees and authorities
• Oversee product labeling and packaging compliance with national regulations, including patient information leaflets and packaging materials
• Lead regulatory intelligence activities, providing strategic advice to cross-functional teams on regulatory requirements for new product development
• Develop and maintain regulatory databases and tracking systems for all submissions, approvals, and renewals
• Train and mentor junior regulatory affairs staff, fostering a culture of regulatory excellence and continuous learning

Required Skills

• Expert knowledge of Rwanda FDA regulatory processes, guidelines, and East African Community harmonization initiatives
• Proven experience in preparing and submitting CTD dossiers for pharmaceutical products in Sub-Saharan African markets
• Strong understanding of ICH guidelines, GMP, GCP, and GDP requirements as applied in the Rwandan context
• Excellent project management skills with ability to manage multiple complex submissions simultaneously
• Outstanding communication and negotiation skills for effective interaction with health authorities and internal stakeholders
• Strategic thinking with ability to anticipate regulatory challenges and develop proactive solutions
• High attention to detail and quality orientation in document preparation and review processes
• Leadership capabilities with experience managing regulatory teams or cross-functional project teams
• Fluency in English and Kinyarwanda; French language skills are a significant advantage
• Proficiency in regulatory information management systems and Microsoft Office applications

Education

Candidates must possess a Master’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a closely related scientific discipline from an accredited institution. Additional professional certification such as Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is highly preferred. Continuous education in regulatory science, pharmaceutical law, or quality management will be considered an asset for this Employment in Rwanda opportunity.

Experience

A minimum of 7 years of progressive experience in pharmaceutical regulatory affairs is required, with at least 3 years in a managerial or leadership role. Candidates must demonstrate successful track record of registering pharmaceutical products with the Rwanda FDA or similar regulatory authorities in the East African region. Experience with both innovative medicines and generic products is desirable. Prior work in multinational pharmaceutical companies and understanding of global regulatory strategies as applied to local markets is essential for this senior Hiring in Rwanda position.

Benefits

• Competitive salary package with performance-based bonuses aligned with industry standards in Rwanda
• Comprehensive health insurance covering employee and immediate family members
• Professional development allowance for continuing education and regulatory certification programs
• Retirement savings plan with company matching contributions
• Annual leave of 24 days plus public holidays as per Rwandan labor law
• Company-provided transportation or transport allowance for daily commute
• Mobile communication package and laptop for remote working capability
• Opportunities for international training and exposure to global regulatory networks
• Wellness programs including annual health check-ups and fitness subsidies

Training

• Comprehensive onboarding program covering Novartis regulatory processes and systems
• Specialized training on Rwanda FDA regulations and submission requirements
• Access to global regulatory affairs training modules and workshops
• Leadership development program for managerial skill enhancement
• Regular updates on changing regulatory landscapes through internal seminars
• Cross-functional training with medical, quality, and commercial teams
• Sponsorship for relevant professional conferences and regulatory forums

Working Environment

You will work in a modern, well-equipped office in Gitarama with a collaborative team environment that values innovation and regulatory excellence. The role involves a hybrid working model with flexibility for remote work balanced with office presence for team collaboration and meetings. You will interact regularly with global regulatory colleagues across different time zones, requiring occasional flexibility in working hours. The position involves minimal travel within Rwanda for regulatory authority meetings, with potential for regional travel to East African Community regulatory harmonization meetings. We foster an inclusive culture that values diverse perspectives and professional growth.

Application Process

Qualified candidates should submit their detailed CV and cover letter through our online application portal. The selection process will include initial screening, competency-based interviews, a practical regulatory case study assessment, and final interviews with senior management. Only shortlisted candidates will be contacted for interviews. The application deadline is three weeks from the date of this advertisement. For additional career resources and Rwanda Jobs in other sectors, please visit https://www.botswanajobsearch.com/.

Equal Opportunity Statement

Novartis Rwanda is an equal opportunity employer committed to building an inclusive and diverse workforce. We welcome applications from all qualified individuals regardless of gender, ethnicity, disability, or background. We provide reasonable accommodations for applicants with disabilities throughout the recruitment process. Our hiring decisions are based solely on qualifications, merit, and business needs.