Walk-In Drive For Regulatory Affairs – API & FML Department in API & FML Division – MSN Laboratories, Corporate Office, Kondapur On Sunday 09-04-2023.
- Regulatory Affairs API & FML Department in API & FML Division , Job Description: ( Regulatory Affairs – API & FML Division ) Should have minimum of 2 to 07 years of experience in API & FML Regulatory Affairs
- Job Title: Executive / Senior Executive / Junior Manager :- Experience: 2 to 7 years in API & FML RA field
- Education: B Pharm \ MSc \ M Pharm
- Department : Regulatory Affairs ( API & 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 : 09-04-2023
Department : Regulatory Affairs API & FML Dept.
Experience : 2 to 07 Years
Position: Executive / Senior Executive / Junior Manager
- Regulatory Affairs API & FML Department in API & FML Division , Job Description: ( Regulatory Affairs – API & FML Division ) Should have minimum of 8 to 12 years of experience in API & FML Regulatory Affairs
- Job Title: Assistant Manager/ Deputy Manager / Manager :- Experience: 8 to 12 years in API & FML RA field
- Education: B Pharm \ MSc \ M Pharm
- Department : Regulatory Affairs ( API & 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 : 09-04-2023
Department : Regulatory Affairs API & FML Dept.
Experience : 8 to 12 Years
Position: Assistant Manager/ Deputy Manager / Manager
Work Location : MSN R&D Center, Pashamylaram, Hyderabad
Interview Venue: MSN Laboratories Pvt. Ltd, Corporate Office, Whitefield’s, Kondapur, Hyderabad, Telangana 91-8452304799/4899 & 040-30438786
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