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.
Date and Time:
- Date : 13-09-2024
- 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
REACH US:
- Contact Person: MVVB Narasimha Raju
- E-Mail: narasimharaju.manthena@msnlabs.com
Requested to bring:
- Resume
- Photo Copy of Educational Certificates
- Latest Increment Letter
- Last Three Months Pay Slips,
- Last Six Months Bank Statements,
- Passport Size Photographs,
- Aadhar Card Copy
- Job Description: (Regulatory Affairs – FML Division ) Should have minimum of 03 to 10 years of experience in FML Regulatory Affairs
- Job Title: Executive / Senior Executive / Junior Manager / Assistant Manager
- Experience: 03 to 10 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
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