Regulatory Affairs Specialist

Key Responsibilities :

• Regulatory Expertise : Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.
• Dossier Management : Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.
• MOH Query Response : Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories.
• Compliance : Review product artworks and samples to ensure compliance with regulatory requirements.
• International Coordination : Liaise with international agents for dossier submission, follow-up, and product registration.
• Documentation : Maintain comprehensive records of technical documentation, product registrations, and related expenses.
• Team Management : Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.

Requirements :

Preferred Qualifications :

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