(Senior) Director* Global Regulatory Affairs Development Pipeline - Project Lead

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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Become a member of the BioNTech Family!

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.

(Senior) Director* Global Regulatory Affairs Development Pipeline - Project Lead

Your purpose on this position is to lead all regulatory activities required for development of investigational medicinal products toward marketing authorisation for global markets. Your main responsibilities are:
  • Act as global regulatory lead for assigned development projects, including concomitant development of diagnostics, and define and execute regulatory strategy from clinical development up to marketing authorisation
  • Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e.g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in scope of product development incl. market authorisation
  • Define regulatory content of regulatory applications and dossiers for product development, marketing authorisation and maintenance; activities include coordination of preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations)
  • Set up, adjust and continuously optimize regulatory processes and interfaces (internal and external); supervise vendors in regulatory affairs on behalf of BioNTech
  • Regulatory Intelligence: Monit changes and evolution in the regulatory landscape for therapeutics and/or diagnostics; analyse the impact of drug/devices changing regulations for BioNTech's products; collect, evaluate and disseminate relevant regulatory updates on competitors' developments

What you have to offer.

  • University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of experience in relevant roles/positions
  • Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
  • Experiences in the field of biological products preferable
  • Knowledge of multidisciplinary functions involved in drug development
  • Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Cancer and Infectious diseases
  • Very structured, accurate and team-oriented way of working
  • Business fluent English is a must

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 onsite parking
· Discounted Home and Auto Insurance
· Pet Insurance
· And more!

Have we kindled your pioneering spirit?

Then apply now for our location Mainz 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).

Job-ID 4250 (please indicate for inquiries) #DCA-LI

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