You are hereCareer for Fresher B.Pharm / M.Pharm / B.Sc / M.Sc as Associate Manager in Novartis India
Career for Fresher B.Pharm / M.Pharm / B.Sc / M.Sc as Associate Manager in Novartis India
Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.
Post: Associate Manager
The following tasks are to be performed as assigned:
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON sup-port, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database en-try activities (specialized department functions).
Key Performance Indicators:
1. Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control.
2. No last minute source document issues identified that could have been prevented by early review of source documents.
3. Ensure that CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines, as appropriate (e.g. measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).
4. Positive customer feedback.
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
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