Walk-in Drive For Regulatory Affairs - Fml Dept @ R&d Center
- MSN Group
- 3 - 8 years
- Hyderabad
- 3 months ago
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Job Description
Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 18-10-2025.
Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 03 to 08 years of experience in FML Regulatory Affairs
Job Title: Executive / Senior Executive / Junior Manager
Experience: 03 to 08 years in FML RA field
Education: B Pharm 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 : 18-10-2025
Department : Regulatory Affairs - FML Dept.
Experience : 03 to 08 Years
Position: Executive / Senior Executive / Junior Manager
Work Location : MSN R&D Center, Pashamylaram, Hyderabad
Interview Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 18-10-2025.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Walk-insContact Details:
Company: MSN GroupLocation(s): Hyderabad
Keyskills: Regulatory Affairs Row Market Europe Market US Market Emerging Markets Drug Regulatory Affairs Labels
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