Associate Director/Director, Global Regulatory Affairs CMC
- Lead the development, implementation, and execution of regulatory CMC strategy
- Ensure all regulatory submissions and CMC projects align with defined regulatory strategy and proactively identify gaps, work with teams to develop mitigation proposals
- Lead and manage preparation of high quality regulatory submission content of the CMC sections to support global clinical development, registration and product life cycle management
- Represent regulatory CMC in global multi-disciplinary meetings/forums that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance and achievement of regulatory department and program objectives
- Participate in Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Ensure that program team colleagues, line management, and partners are informed of developments that may affect regulatory success
- Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.
What you have to offer.
- Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
- 6+ years professional working experience in Regulatory Affairs CMC during clinical, registration and/or post-marketing preferably in cell and gene (Advanced Therapy Medicinal Products or biopharmaceutical products.
- Extensive experience in preparation and revision of regulatory CMC documents for US, EU and MOW
- Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
- Result-and goal-oriented
- Excellent communication skills in English
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
- Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
Benefits for you.
- Medical, Dental, and Vision Insurance
- Life, AD&D, STD, and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
- And more!
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm CET).
Job-ID 6564 #LI-DCA (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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