Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier submissions in different countries - Evaluating and responding to queries, including coordination with manufacturers and final compilation of responses - Managing post-approval activities such as product lifecycle management, variations, and renewals - Monitoring harmonization of dossiers, queries, and variations across all countries - Developing artworks and obtaining approvals as per standard operating procedures - Engaging in daily communication with internal departments and external stakeholders - Updating trackers for queries and variations regularly - Attending unit and regional meetings, trainings, and other relevant sessions as required by the line manager and Intellectus Campus. Your role will require strong technical expertise in regulatory affairs, excellent communication skills, attention to detail, and the ability to manage multiple tasks while ensuring deadlines are met. Your proactive approach to problem-solving and ability to collaborate with various stakeholders will be crucial for success in this position.,

Posted 2 weeks ago

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