Regulatory Affairs Manager

Job Description

Job Title: Regulatory Affairs Manager Location: Chembur Years of Exp-6+ Mandatory-Only Candidates from Pharmaceutical Industry and that too into Formulation. 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: 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 Interested candidates can share resume on saloni@digifocal.in