MSN Laboratories - Walk-In on 27th Jan 2024 for B.Pharm, M.Pharm, M.Sc
Walk Interview For MSN Labs
• Qualification: B.Pharm, M.Pharm, M.Sc
• Experience : 03-08+years
• Department: Regulatory Affairs – FML
• Job Location: Hyderabad,Telangana
• Openings: 30
• Position: Executive / Senior Executive / Junior Manager / Assistant Manager
Time and Venue:
Walkin Interview on 27th January from 9.30 AM – 2.00 PM onwards
M/s MSN Laboratories Pvt. Ltd. R & D Center Plot No. 12 Phase IV, Industrial Park, Telangana State, Industrial Infrastructure Corporation Pashamylaram (Village), Patancheru (Mandal) Medak (District), Telangana State 502 307
Job description:
Walk-In Drive For Regulatory Affairs – FML Department in FML Division – MSN Laboratories, R&D Center on Saturday 27-01-2024.
Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs – FML Division ) Should have minimum of 03 to 09 years of experience in FML Regulatory Affairs
Job Title: Executive / Senior Executive / Junior Manager / Assistant Manager
Job Profile:
International Product filing Registrations and life-cycle management
• Expertise in Regulatory Norms for regulated markets / emerging market.
• dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements
• Respond to queries raised by regulatory agencies and/or local partners of the above regions
• Review and give regulatory feedback on technical documents like process validation, AMV, Stability and composition, labeling, batch records, specification or test methods, etc. Ensure accuracy and compliance of documentation
• Artwork recommendations and approvals as per regulatory provisions
• Well-versed in ICH guidelines, maintain awareness of legislation and current developments in regulatory affairs
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