Regulatory Affairs Specialist - CMC (USFDA) vueverse.

7.0 - 11.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data. It will be essential for you to coordinate effectively with manufacturing units to ensure that products and processes align with regulatory requirements. Additionally, staying informed about the evolving USFDA regulations will be crucial, enabling you to provide impact assessments and strategic guidance to the organization. To excel in this role, you should possess a minimum of 7-10 years of hands-on experience in Regulatory Affairs CMC, with a specific focus on USFDA filings, particularly ANDAs. A strong understanding of ICH guidelines, USFDA regulations, and the regulatory frameworks applicable to generic drug products will be required. You should also have experience in preparing and reviewing technical documents in Module 2 & 3 (CTD format) and exposure to quality systems, BMR review, and interaction with production/plant teams. Your ability to manage the end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA, will be critical to your success in this role.,

Posted 2 weeks ago

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Sr. Associate - Regulatory Affairs (CMC) Endo

3.0 - 7.0 years

0 Lacs

jharkhand

On-site

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,

Posted 1 month ago

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