Regulatory CMC Associate Director - Cell And Gene Therapy

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 2 months ago

Job Description:
200+ projects in development. 20 major approvals. 20 major submissions. And that's just in 2018. This is your chance to help reimagine medicine in 2019. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world via flexible, family friendly arrangements. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.
1.Independently formulate and drive global CMC regulatory strategy for cell and gene therapy products in development and commercial phase, conduct risk assessments and develop mitigation strategies.2. Represent Global Regulatory CMC on interdisciplinary project teams and main-tain sound working relationships with partners and customers.
3.Lead global CMC submission activities including identifying required content to ensure compliance in meeting global regulatory requirements.
4.Author and/or review CMC documentation for Health Authority submissions.
5.Coordinate and lead FDA interactions and negotiations and support global Health Authority interactions for CMC topics.
6.Possess knowledge on current regulatory guidelines and requirements in all global regions.
7.Influence external regulatory environment to support company interests.
8.Provide guidance and mentor junior staff.
9.Lead training activities to share regulatory requirements.
10. Support business objectives and lead initiatives within department and Division.

Employment Type

Regular


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Regulatory CMC Associate Director - Cell And Gene Therapy

Novartis Pharmaceuticals