Regulatory Affairs CMC Associate Director @ Novartis
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Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. Join Novartis as a Regulatory Affairs CMC Associate Director in Schaftenau, Austria (3 days per week on site) and help bring innovative therapies to patients faster.
About The Role
Key Responsibilities:
- Formulate, lead, and drive global CMC regulatory strategy for Biologics or Small Molecules.
- Coordinate global CMC submission activities including planning, authoring, and review.
- Identify documentation needs and negotiate delivery of technical source documents.
- Author and review high-quality CMC documentation for Health Authority submissions.
- Represent Global Regulatory CMC on cross-functional project teams and maintain stakeholder partnerships.
- Initiate and lead Health Authority interactions including briefing preparation and risk mitigation.
- Provide strategic advice and direction within the department and cross-functional teams.
Essential Requirements
- Science degree (Chemistry, Pharmacy, Biochemistry, etc.) or equivalent; advanced degree is a plus.
- Minimum 8 years of regulatory or pharmaceutical industry experience.
- In-depth understanding of regulatory submission and approval processes.
- Ability to evaluate complex CMC regulatory issues across various scientific disciplines.
Why Novartis?
At Novartis, we reimagine medicine to improve and extend lives. You will receive a competitive base salary, an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities. Additional benefits can be found in the Novartis Life Handbook.
Commitment to Diversity & Inclusion
Novartis is committed to an inclusive work environment and diverse teams. Applicants requiring adjustments due to disabilities may contact disabilities.austria@novartis.com.
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Benefits and Rewards
Learn more about our comprehensive benefits and rewards by visiting our careers website.
Key skills/competency
- regulatory
- submission
- strategy
- documentation
- compliance
- negotiation
- cross-functional
- planning
- technical
- global
How to Get Hired at Novartis
🎯 Tips for Getting Hired
- Research Novartis culture: Study mission, values, news, and employee insights.
- Customize your resume: Highlight relevant regulatory and CMC experience.
- Tailor your cover letter: Emphasize global submission achievements.
- Prepare for interviews: Review regulatory guidelines and strategic projects.