Novartis India is hiring for the role of Sr. Executive MRC in Mumbai location. Interested candidates can apply for this recruitment drive and register through the given link. The detailed eligibility criteria to qualify and the application process are given below (For More Job update: Jobsmela).
Job Summary of Novartis India:
Company Name: Novartis India
Location: Mumbai
Job Role: Sr. Executive MRC
Job Description
Provide and ensure timely preparation of high quality CMC regulatory documentation and support in line with global regulatory submission plans and strategies.
Minimum Requirements
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)
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This notification is for the recruitment of Sr. Executive MRC from Novartis India. You can apply through the given link for the profile of the Sr. Executive MRC.