The Reg. CMC Associate Director will independently, provide strategic and operational global CMC regulatory direction and documentation for projects/products within responsibility covering development, registration and approval/post approval activities as assigned.
1. Independently formulate and drive global CMC regulatory strategy for development projects or marketed products, conduct risk assessments and develop mitigation strategies.
2. Represent Global Regulatory CMC on interdisciplinary project teams and maintain 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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology) or equivalent required Desirable: Advanced Degree in Science desirable English
6 years pharmaceutical industry experience in CMC drug development, QA/QC, and/or Technical Operations;
6-8+ years regulatory CMC experience; Strong knowledge of global regulatory requirements and experience in regulatory submissions, approvals, and product life cycle management.
Good oral and written communication skills
Strong organizational skills
Proven excellence in working on interdisciplinary teams
Demonstrated strong leadership and negotiation skills
Strategic thinking and strong problem solving skills
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