Dy Manger/Manager/AGM For FML Regulatory Affairs Dept (RA)

Job Description

Urgent Requirement For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 13 to 23 years of experience in FML Regulatory Affairs Job Title: Deputy Manager / Manager / Senior Manager / AGM Experience: 13 to 23 years in FML RA field Candidates Only. Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Markets : China, Europe, Australia, US, ROW Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities 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 . Interested candidates share their CV to narasimharaju.manthena@msnlabs.com