Website Cipla Pharmaceutical
If You are Looking for Jobs in Mumbai, Check out this Team Member Job vacancy in Mumbai. Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle
Your Duties And Responsibilities as a Team Member
- Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time.
- Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisation.
- Maintain, and update product dossier as required to meet changes in Cipla internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
- Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
- Provide Regulatory support throughout the life cycle of the product for smooth functioning
- Provide the information and availability of dossier for out-licensing and in-licensing
- Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done
Requirements / Who Can Apply For This Position
- Communication Skills (clarity of thought, comprehension) Likely potential for growth Job / Product / Technical Knowledge / Pharma domain knowledge.
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem solving abilities
- Productivity & Result Orientation (If applicable)
Job Details Company Name : Cipla Pharmaceutical Location : Mumbai Job Type : Full-Time