MSN Group is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India.Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified,
Job Description
- Department: Regulatory Affairs -API & FML Dept
- Designation: Executive / Senior Executive / Junior Manager
- Qualification: B.Pharm, M.Pharm, M.Sc
- Experience : 03-08+years
- Job Location: Hyderabad/Secunderabad
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
Walk in Interview on 3rd June 2023
Time: 9.30 AM – 5.30 PM onwards
Venue: MSN Laboratories Pvt Ltd MSN R&D Center, Isnapur, patancheru, Pashamylaram
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