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Manager/Sr. Manager - Regulatory Affairs - US Market Umedica Labs

12.0 - 15.0 years

10 - 18 Lacs

navi mumbai

Work from Office

Role & responsibilities Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support for complex formulations , including injectables and liquid dosage forms Collaborate with R&D, QA, QC, ...

Posted 1 month ago

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