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

Walk-In Drive For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center on Friday 27-12-2024.

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 Title: Executive / Senior Executive :- Experience: 02 to 07 years in FML RA field

Education: B Pharm \ MSc \ M Pharm

Department : Regulatory Affairs - FML

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 : 27-12-2024
Department : Regulatory Affairs - FML Dept.
Experience : 02 to 07 Years
Position: Executive / Senior Executive / Junior Manager
Work Location : MSN R&D Center, Pashamylaram, Hyderabad

Interview Venue:
M/s MSN Laboratories Pvt. Ltd.

MSN House, Plot No :, MSN, C-24, Industrial Estate, Sananth Nagar,
Hyderabad, Telangana 500049