Walk-In Drive For Regulatory Affairs – FML Department in FML Division – MSN Laboratories, R&D Center on Thursday 24-10-2024.
Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs – FML Division ) Should have minimum of 03 to10 years of experience in FML Regulatory Affairs
Job Title: Executive / Senior Executive / Junior Manager / Assistant Manager / Deputy Manager / Manager / Senior Manager
Experience: 03 to 20 years in FML RA field Candidates Only.
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 : 24-10-2024
Department : Regulatory Affairs – FML Dept.
Experience : 03 to 20 Years
Position: Executive / Senior Executive / Junior Manager / Assistant Manager / Deputy Manager / Manager / Senior Manager
Work Location : MSN R&D Center, Pashamylaram, Hyderabad
Interview Venue:
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
Phone: 0845-2304789 or 0845-230/4899/4799