MSN Laboratories Released Job Openings On 23/01/2023.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, this Hyderabad-based venture has nine API and five finished dosage facilities established across Hyderabad, USA and Myanmar
MSN Laboratories Recruiting BPharm,MPharm,MSc with 02-07 years experience for Executive / Senior Executive FML Regulatory Affairs position.Complete Details for the Executive / Senior Executive FML Regulatory Affairs as follows.
Important Details :
- Location : Hyderabad/Secunderabad
- Details of Salary: ₹ 3,00,000 – 8,00,000 P.A.
- Opening date for online Application: 23/01/2023
- Mode of application :Online
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Job Description/Skills Required
Product Registrations and life-cycle management
- Expertise in Regulatory Norms of European markets EMA.
- dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements
- Respond to queries raised by MOH 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
- BPharm/MPharm/MSc/ candidates with relevant experience may apply
- Exposure to Formulations required
- Excellent written and oral English Language skills
- Exposure to European filings preferred