Vacancy:
This position is key to ensure business continuity, regulatory compliance, and timely market access across West Africa region.
Location: Madagascar
Key responsibilities:
- Registration & Regulatory Compliance
- Manage the registration of pharmaceutical products and medical devices with local health authorities (DPML, DPM, DPH, etc.) in African countries.
- Prepare, submit, and follow up regulatory dossiers (CTD, simplified files, variations).
- Ensure ongoing compliance of products with local requirements (formulations, labeling, packaging, leaflets).
- Renew Marketing Authorizations within required timelines.
- Relations with Health Authorities
- Represent the company during inspections, audits, meetings, or evaluation committees.
- Anticipate and interpret regulatory changes in the region.
- Internal & External Coordination
- Collaborate with international suppliers to obtain the required regulatory documentation.
- Support sales and marketing teams in promotional materials.
- Work closely with quality and logistics to ensure the legal importation and distribution of products.
- Training & Advisory
- Train internal teams (sales, marketing, logistics) on local regulatory requirements.
- Provide strategic advice to management on the regulatory implications of business decisions (new products, variations, withdrawals).
- Post-Marketing Surveillance
- Manage pharmacovigilance obligations in coordination with local authorities and partners.
- Ensure the follow-up of product complaints and possible recalls.
- Regulatory & Strategic Monitoring
- Continuously monitor regulatory and legislative changes in FSWA.
- Advise the company on opportunities and risks related to these changes.
Candidate profile:
- 5+ years of experience in regulatory affairs in the pharmaceutical industry.
- Knowledge of national, regional & international regulatory frameworks is desirable.
- Strong background in dealing with health authorities (DPM, DPML etc.).
- Strong command of labeling, packaging, and artwork requirements in the region.
- Ability to manage multiple country registrations simultaneously.
- Excellent communication and negotiation skills with authorities and partners.
- Detail-oriented and strong analytical thinking.
- Ability to work under tight deadlines and handle multiple priorities.
- Team player with cross-functional collaboration.
- Fluent in French (mandatory) and proficient in English (to liaise with international partners).
- High level of integrity and compliance mindset.
What we offer:
- Competitive fixed salary + attractive performance-based additional benefits
- Autonomy and strategic involvement in decision-making
- A mission-driven company with real-world impact in healthcare access
- Exposure to cross-functional international teams and career development
If you are interested, please send your CV to the following e-mail ID: direction.rh@atomepharma.com
Deadline for application submission: Feb 18, 2026 at 4:00 pm GMT