Assistant Manager/ Manager Regulatory Affairs Emcure Pharmaceuticals Limited

7.0 - 11.0 years

0 Lacs

pune, maharashtra

On-site

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing change controls and performing gap analysis for new product filings. Additionally, you will be tasked with maintaining product life cycles and collaborating with cross-functional departments to evaluate, approve, and implement change proposals, deviations, and escalations. Furthermore, you will be responsible for preparing internal guidance documents to support regulatory activities within the organization. This position is based in Pune and focuses on the Canadian market, encompassing all types of dosage forms. A degree in B.Pharm/M.Pharm is required to qualify for this role.,

Posted 1 month ago

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