Opportunity for M.Pharm/B.Pharm to work as Team Member - Regulatory Affairs (Plant) in Mylan
Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Team Member - Regulatory Affairs (Plant)
Areas of Responsibility
The Team Member- Regulatory Affairs (Plant) will have the following key responsibilities:
1. Licensing activities – Preparation & Verification of Manufacturing Licences for Finished dosages, DCGI NOC’s – Form 29(Test Licence), Export, Import of Finished Product and API for Nashik, Aurangabad Plant and Mission Vivacare (our third party plant) and MPPL, Form 46 Compilation – New Product Approval, COPP compilation & verification (For ROA Countries). Liaise & Follow up with State FDA for Approval of product permission/Licences and COPP’s Follow up with WHO GMP Office. Coordination for documents for Appointment /Intimation of Assistant Staff to FDA for Certification.
2. Art works Review as per regulatory commitments/ requirements and Approval for US & South Africa Commercial Market, Mission Pharma for timely launch of Products.
3. Review and approval of Packaging material Specifications.
4. Review and approval of Technical data - BMR, BPR, Stability data, artworks, post approval stability Protocol and report, as per the regulatory requirement for commercial launch of new product for South Africa, Domestic Market and of Mission Pharma (our third party unit).
5. Timely submission of technical data in response to queries of South Africa Market.
6. Technical documents review and approval for successful and timely execution of exhibit batches of South Africa & other markets.
- General understanding of regulatory guidelines
- Knowledge of pharmaceutical development/ chemistry
Experience: Fresher (or) 1-2 Years of FDF experience
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 15th Jan, 2013
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