We are currently seeking a qualified candidate for the role of Regulatory Affairs Manager for our client in Kinshasa, a Healthcare technology and Pharma company for an undetermined long-term contract .

Key area of responsibilities :

• In cooperation with the partners, ensure timely and compliant preparation of registration dossiers, address complaints, deficiencies or additional requests from regulatory authorities
• Manage the interactions with regulatory authorities through local representatives, ensuring effective and timely resolution of issues
• Provide regulatory advice and guidance to cross-functional teams and objectives, clinical (BA/BE/CT trials) and medical aspects    
• For cases of regulatory changes, provide recommendations for action
• Provide leadership, coaching, and mentoring to regulatory affairs team members to ensure their professional development andsuccess.

Knowledge & Education level :

• BPharm / M Pharm degree
• Minimum of 10 years of experience in regulatory affairs in the pharmaceutical industry African markets, with at least 5 years in a leadership role
• In-depth knowledge of regulatory requirements and guidelines in regulated markets 
• Strong communication and interpersonal skills, with the ability to lead and collaborate effectively with cross-functional teams and external partners
• Strong organizational and project management skills, with the ability to prioritize and manage multiple projects simultaneously
• Fluency in French and English.