Director* Regulatory Affairs GRA CMC

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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.

You will lead all aspects of Regulatory Affairs CMC for Investigational Medicinal Products in clinical programs of mRNA-based platforms and bring new medicinal products of these platforms on the market. As you guide the products along this exciting path, you will establish new regulatory routes and define requirements for these next generation of therapeutics. In your role, you will act globally and work cross-functionally in an exciting international team.
 

Responsibilities

  • Act as global regulatory CMC lead for assigned development programs of a therapeutic and define and execute Regulatory CMC Strategy from pre-clinical stage up to (including) Marketing Authorization. Identify critical Regulatory CMC development issues and proactively implement activities for their resolution.
  • Plan, prepare and conduct all CMC related topics/aspects for interactions with national authorities and sovra-national agencies (e.g., MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorization.
  • Define for regulatory CMC content of regulatory application and dossiers for product development, marketing authorization and maintenance. Activities includes coordination of preparation, writing and reviewing of CMC relevant documents and dossiers (e.g. briefing book, IND m3, BLA)
  • Set up, adjustment and continuous optimization of regulatory CMC processes and interfaces (internal and external).
  • Regulatory Intelligence: Monitoring of changes and evolution in the regulatory CMC landscape for therapeutics; analyze the impact of drug changing regulations for BioNTech´s products; collect, evaluate, and disseminate relevant regulatory updates on competitors´ developments.

What you have to offer.

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
  • At least 9 [BV1] years of professional experience in Global Regulatory Affairs CMC during clinical, registration, and/or post-marketing for Biologics, Vaccines, and/or Small Molecules
  • Extensive experience in the preparation and revision of regulatory CMC documents
  • Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
  • Excellent communication skills in English (German knowledge is helpful[BV2] )

Benefits for you.

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HSA & 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 subsidized parking
  • Discounted Home and Auto Insurance
  • Pet Insurance

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.

Job-ID 6995 (please indicate for inquiries) #LI-DCA

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