Regulatory CMC Associate Manager-ii Information

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Novartis Healthcare Pvt Ltd

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 Stoc... Read More

Address	Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website	www.novartis.in/
Holding	No Holding Details

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Regulatory CMC Associate Manager-ii

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). 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). Desired Profile Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. English 1. 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals 2. Working knowledge of chemistry/biotechnology, analytics or phar-maceutical technology. Knowledge of the drug development pro-cess desirable. Ability to critically evaluate data from a broad range of scientific disciplines. 3. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. 4. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. 5. Effective planning, organizational and interpersonal skills. 6. Reasonable approach to risk assessment. 7. Excellent written/spoken communication and negotiation skills. 8. Computer literacy. Experience 0 - 4 Years Industry Type Pharma / Biotech / Clinical Research Role Regulatory Affairs Manager