MSN Laboratories Pvt. Ltd Walk-in 26th April 2025 for Executive / Senior Executive- Regulatory Affairs – FML

Walk-In Drive For Regulatory Affairs – FML Department in FML Division – BloomSuites | Electronic City, 56/A, Opp. Wipro Gate No. 5, Electronic City Phase 1, Hosur Road, Bengaluru, on Saturday 26-04-2025.

Regulatory Affairs FML Department in FML Division ,

Job Description: ( Regulatory Affairs – FML Division ) Should have minimum of 02 to 07 years of experience in FML Regulatory Affairs

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

Interview Date : 26-04-2025

Time and Venue

26 April , 9.30 AM – 4.00 PM

Bloom Suites | Electronic City, 56/A, Opp. Wipro Gate No. 5, Electronic City Phase – 1, Hosur Road, Bengaluru, 560100.

Contact – M B V V N Raju ( 9100376029 )