Director / Senior Director*, Global Regulatory Affairs CMC (Hybrid & Remote)

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Company Summary

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

Primary Responsibilities

You will lead all aspects of Regulatory Affairs CMC throughout clinical development. and commercial lifecycle of personalized mRNA oncology vaccines.  As you guide these products along this exciting path you will deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear or specific regulatory guidance.  In this role you will work globally both independently and in a collaborative team environment with the flexibility and strength to navigate multiple disciplines and personalities
  • Lead the development, implementation, and execution of regulatory CMC strategy internally and in collaboration with partners
  • 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 and partner 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
  • 8+ years professional working experience in Regulatory Affairs CMC during clinical, registration and/or post-marketing preferably in oncology 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
  • Knowledge of industry landscape for regulating bioinformatics software a plus
  • 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?

Then apply now for our location Cambridge, Massachusetts and simply send us your application documents using our online form.

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 7299  #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!

BioNTech - As unique as you

https://biontech.de