Regulatory Affairs Manager - Pharma

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 : . Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets.
• Experience in compiling and reviewing ACTD and CTD dossiers. Proficiency in handling MOH queries and ensuring timely responses.
• Strong attention to detail in checking product artwork and samples for regulatory compliance.
• Ability to effectively coordinate with international agents and manage the dossier submission and registration processes
• Solid organizational skills for maintaining technical documentation and tracking expenses.. Team management

(ref : iimjobs.com)