MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable.
DATE AND TIME:
Date : 26-04-2025
TIME: 9.30 AM – 4.00 PM
VENUE:Bloom Suites | Electronic City, 56/A, Opp. Wipro Gate No. 5, Electronic City Phase – 1, Hosur Road, Bengaluru, 560100.
Contact – M B V V N Raju ( 9100376029 )
JOB DESCRIPTION:
- Qualifications: B Pharm \ MSc \ M Pharm
- Experience:2 to 07 years in FML RA field
- Designation:: Executive / Senior Executive- Regulatory Affairs – FML
Important Details :
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
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 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
Documents:
All Educational Certificates
Last 3 Months Payslips
Last 3 Months Bank Statements
Last Increment Letter
Aadhaar Card
PAN Card
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