(Senior) Director* Global Regulatory Affairs - Diagnostics Regulatory Expert

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

The company was founded on the notion that every cancer patient is unique and should receive individualized therapy. This vision requires Precision Medicine expertise.
 
BioNTech is seeking a Diagnostics Regulatory Expert for Global Regulatory Affairs that can provide strategic and operational regulatory leadership across the pipeline for projects that require co-development and registration of an in-vitro diagnostic. This role will have the opportunity to break new ground in regulatory for several cutting-edge technologies such as liquid biopsies and in the context of highly innovative development program.
The Diagnostics Regulatory Expert will be accountable to work with the Global Regulatory Lead and Diagnostics Team to develop clinical assets and deliver marketing authorizations for our products globally.
 
The (Senior) Director, Diagnostics Regulatory Expert will work within the Development Pipeline team of BioNTech´s Global Regulatory Affairs department and will have a key role contributing to the global regulatory strategy that enables the organization to achieve its global development objectives. Successful execution of strategy will comply with both internal processes and with appropriate regulatory requirements to deliver optimal market labeling. This role requires an experienced and innovative leader capable of developing and executing regulatory diagnostic strategy under US and EU regulations. They will lead and/or collaborate with Legal Manufacturers for interactions with Health Authorities that regulate diagnostics, including FDA and EMA. Additionally, it requires hands-on experience of operations successfully supporting the development of innovative products for cancer and other diseases.  
 
A successful Diagnostics Regulatory Expert  will build effective partnerships with regulatory counterparts in Germany and the projects/product/program teams, including teams from co-development partners and external vendors.

(Senior) Director* Global Regulatory Affairs - Diagnostics Regulatory Expert

BioNTech is seeking a Diagnostics Regulatory Expert for Global Regulatory Affairs that can provide strategic and operational regulatory leadership across the pipeline for projects that require co-development and registration of an in-vitro diagnostic. This role will have the opportunity to break new ground in regulatory for several cutting-edge technologies such as liquid biopsies and in the context of highly innovative development program.
The Diagnostics Regulatory Expert will be accountable to work with the Global Regulatory Lead and Diagnostics Team to develop clinical assets and deliver marketing authorizations for our products globally.
Your main responsibilities are:
  • Act as Diagnostics Regulatory Expert as part of the Regulatory Sub-Team (RST) for the assigned development projects
  • In alignment with the Global Regulatory Lead (GRL) and BioNTech Diagnostics team, define and execute co-development diagnostic regulatory strategy (including but not limited to IUO, IVD and CDx) to support global clinical development objectives including post-market approvals and enable optimal market labeling for diagnostics; assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval
  • Support the management and supervision of diagnostic vendors and development partners on behalf of BioNTech ensuring alignment between diagnostic development and clinical development objectives and timelines; serve as subject matter expert for BioNTech in the interface with IVD manufacturers and provide oversight as part of the established partnership governance
  • In partnership with the GRL, Diagnostic team, Clinical Development team, and third parties, lead the preparation of diagnostics-related regulatory submissions, including authoring, SME coordination and review of key regulatory documents
  • Plan, prepare and conduct interactions with Health Authorities (e.g. CDRH, EMA, Notified Bodies etc.) as appropriate in coordination with Legal Manufacturers in the scope of diagnostic development
  • Monitor regulatory and competitive landscape for diagnostics; analyze the impact of drug-device regulation changes for BioNTech's products; collect, evaluate and disseminate relevant updates as appropriate. Provide regulatory advice to all stakeholders in support of development
  • Build and modify existing processes and interfaces (internal and external) to continuously improve organizational efficiency

What you have to offer.

  • University degree, preferrably Master's, in a scientific discipline, added with at least 10 years of experience in regulatory affairs within the biotech or pharmaceutical industry, including experience interacting with CDRH
  • Significant experience and successful leadership in regulatory aspects of diagnostics development (IUO, IVD, CDx etc.)
  • Understanding of co-development involving complex diagnostic devices or diagnostic testing services based on biomarkers; experience with regulatory requirements for bridging studies and method comparison studies
  • Experience with EU and/or US regulatory device submissions, e.g. IDE, 510k, PMA etc.; good understanding of the EU IVDR, including relevant requirements and impact on diagnostics development and approval of companion diagnostics in the EU
  • Experience collaborating with vendors to support device development in alignment with clinical development programs, hands-on strategic and operational experience in co-development of in-vitro diagnostics and therapeutic products from early clinical phase to market approval  
  • Regulatory or scientific experience with anti-cancer immunotherapy, cell or nucleic-acid-based therapy, antibodies, or other advanced biologics is preferred.
  • Experience working with external medical/scientific experts to support development planning and strategy
  • Experience contributing to an oncology IND and NDA/BLA is preferred

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 and simply send us your application documents using our online form.

Job-ID 4883 (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!

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