Walk-In Drive For Regulatory Affairs - FML Dept @ R&D Center

Job Description

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025. Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 08 to 13 years of experience in FML Regulatory Affairs Job Title : Asst. Manager / Deputy Manager / Manager / Sr Manager Experience : 08 to 13 years in FML RA field Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Roles & Responsibilities : Collect documents from various departments to prepare regulatory submissions. Prepare regulatory submissions to relevant authorities. Prepare amendments, updates, and revisions to submissions. Conduct meetings with cross-functional teams (CFT) to address deficiencies received from regulatory authorities and customers. Draft responses to regulatory deficiencies and review comments. Update the database as per requirements. Prepare the applicant and restricted parts for Abbreviated New Drug Applications (ANDAs). Compile dossiers in electronic Common Technical Document (eCTD) and Common Technical Document (CTD) formats for all relevant countries. Guide the CFT based on current requirements from regulatory authorities. Plan and allocate projects within the team. Assess proposed changes for approved products and finalize the submission category. Review and clear specifications, protocols, stability data, bio-waivers, etc. Key Performance Indicators: Demonstrate in-depth knowledge of regulatory guidelines and requirements for each market. Ensure all submissions are cleared within the stipulated timeline. Provide actionable items to address regulatory queries and dossiers. Required skills : Knowledge of RA Guidelines and Requirements Action Item for RA deficiency. Cross-Functional Team Work Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities Support plant teams in regulatory audits, liaison with domestic & export regulatory authority. Assess and approve change controls and update files accordingly Interview Date : 27-05-2025 Department : Regulatory Affairs - FML Dept. Experience : 08 to 13 Years Position: Asst. Manager / Deputy Manager / Manager / Sr Manager Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025.