Regulatory CMC Associate Director - Biologics job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
1. Independently formulate and drive global CMC regulatory strategy for devel-opment projects or marketed products, conduct risk assessments and develop mitigation strategies for biologics products. 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.|
1. Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. 2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate. 3. Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits. 4. As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 5. Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. 6. Establish and maintain a single point of contact with FDA or CPOs, DRA regional and TA groups for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers. 7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk miti-gation plans. 8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate. 9. Lead, prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions and escalate to management as appropriate. 10. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. 11. Represent Reg CMC on due diligence teams for in-licensing and divestment opportu-nities. 12. Participate on teams for continuous improvement within and outside the department to continuously improve working practices and processes. 13. Provide advice and direction within the department within specialized assignments as assigned and by utilizeDegree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology) or equivalent required Desirable: Advanced Degree in Science desirable Fluent English required (oral and written). Good skills in site (local) language desired (oral) 1. 6 years pharmaceutical industry experience in CMC biomolecule de-velopment and/or manufacture, testing 2. 6-8+ years biologics regulatory CMC experience 3. Strong knowledge of global biologics regulatory requirements and experience in regulatory submissions, approvals, and product life cycle management.