Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager Reg CMC
Job Description
1. Management of the team and cross-functional co-ordination in absence of the team leader.
2. Participate in global regulatory initiatives and improvement projects (e.g. systems, global proce-dures, softwares, information/document management etc)
3. Taking a lead in HA preparation activities within department and representation of RegCMC department in HA Inspection
4. Management of Trainings/meetings within department on special/complex topics, Quality Systems, GOPs, databases etc.
5. Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management)
6. Support to tracking budgeting and invoicing activities within department
7. cGMP support to NTO/ESO organization as and when needed
8. New submissions in Most of World (MoW) regions and its planning as per targets. Management of registration samples/standards.
9. Life cycle management of approved Marketing Authorizations (MAs) of Complex Products
10. On board, on-job training and grooming of new associates within team
11. Review of regulatory applications and variation packages prepared by associates
12. Actively participate as a member of the global RegCMC team by contributing to the regulatory strat-egy, identifying the critical issues and lessons learned.
13. Act as a SPOC for global regions and for specific projects.
14. Act as a key account manager (KAM) for NTO site(s)
15. Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
16. Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
17. Prepare CMC responses to health authority questions during development, registration and product lifecycle
Candidate Profile
Post Graduate in Pharmacy or Science (e.g. Organic Chemistry, Analytical chemistry) or equivalent Additional courses in Drug Product Regulatory Affairs would be added advantage English Minimum 12+ years of experience in RegCMC area
Additional Information:
Job ID: 224467BR
Experience: 12+ years
Location : Navi Mumbai
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 25th Octo, 2017
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