A global healthcare leader, 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 : Sr. Executive MRC
Job Description
1. New submissions in Most of World (MoW) regions and its planning as per targets
2. Life cycle management of approved Marketing Authorizations (MAs)
3. 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.
4. Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulato-ry compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
5. Prepare CMC responses to health authority questions during development, registration and prod-uct lifecycle.
6. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc) for possible regulatory impact
7. Identify the required documentation for regulatory submissions and negotiate the delivery of ap-proved technical source documents in accordance with project timelines.
8. Identify content, quality and/or timeliness issues with source documents, or any other potential au-thoring issues that may impact submission quality or timelines, as early as possible.
9. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global re-gions as well as for new technical trends. 10. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. 11. Establish and maintain sound working relationships with partners, stakeholders and customers.
12. Assume activities in support of the global regulatory databases such as Trackwise, SAGE, SELECT, RegDB, VarDB support, annual and product renewal plan, coordination/collection/storage of source documentation needed for submission to HAs, other database entry activities (special-ized department functions).
13. Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management)
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 7+ years of experience in core Reg CMC areas
Additional Information:
Experience: 7+years
Location: Mumbai
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Research & Development
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