Senior Director, Regulatory Affairs*
- Cambridge (Boston)
- Senior, very experienced
- Executive Middle Management
- Quality Management, Quality Assurance
- Research, development, teaching
Director, GCP Quality Assurance*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech is seeking a Regulatory Affairs leader for our US activities for multiple products in oncology/immuno-oncology, rare, and infectious diseases under development. The newly hired director will have the opportunity to break new ground in regulatory for several cutting-edge and personalized medicine technologies and be accountable to develop clinical assets and marketing authorizations in US.
The Senior Director, Regulatory Affairs (SDRA) will have a key role contributing to build a successful global clinical development organization in the US and will participate in interactions with the FDA. The primary responsibilities include participation in defining and implementing the strategy from First-in-human trial until marketing authorization and subsequent adjustments. Furthermore, the SDRA will be responsible in overseeing the regulatory affairs and submissions activities for therapeutics and diagnostics in the US.
Finally, the director will be responsible for ensuring alignment on regulatory strategy, activities, and timelines between project, product, and program teams in the US and Germany. And will build effective partnerships with regulatory counterparts in Germany as well as key stakeholders, in teams from co-development partners and external vendors.
Here, you’ll achieve greatness.
- Participate in the definition of the regulatory strategy for US territory on product/program-level and align to the Global Clinical Development Plans (CDP) for BioNTech products/programs
- Evolution of Target Product Profiles (TPP) by bringing strategic regulatory expertise to the process
- Identify and engage with external advisors/consultants, as necessary, to formulate US regulatory strategies for BioNTech products/programs
- Provide regulatory support in preparation of documents such as Investigator Brochure, clinical study protocols, and Informed Consent
- Provide regulatory advice to all stakeholders in support of the development of clinical study reports
- Plan and supervise preparation and filing of regulatory submissions for assigned products/programs from IND, IDE to NDA/BLA, PMA as well as Fast Track, Breakthrough, RMAT and ODD to US agencies and institutions
- Plan, supervise, and represent BioNTech US at regulatory agency meetings
- Interpret and explain regulatory agency communications to stakeholders across BioNTech US program/project teams to ensure accurate functional area responses to agency requests and comments
- Represent BioNTech US on co-development teams and liaison with co-development partners on regulatory planning and strategy
- Participate in building the Regulatory Affairs team in US i.e. hire and manage nternal regulatory affairs and regulatory operations personnel
- Stay current on changing regulatory environment, advise BioNTech on new and changing regulations that may impact ongoing development programs, and work with QA to implement new or changed operating procedures for ongoing programs
What you have to offer.
- Industry Experience:
- At least 10 years’ experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the FDA; experience with CBER preferred
- Prior work experience at the FDA is a plus
- Experience with US regulatory submissions, Orphan Drug Designation, Rolling BLA, Fast Track and Breakthrough therapy designations in the US considered a plus
- Experience planning and managing complex regulatory submissions
- Regulatory or scientific experience with anti-cancer immunotherapy, cell or nucleic-acid-based therapy, antibodies, or other advanced biologics
- Understanding of co-development involving diagnostic devices based on biomarkers preferred
- Experience collaboratively developing Target Product Profiles is required
- Experience developing and implementing a Clinical Development Plan is required
- Experience working with external medical/scientific experts to support development planning and strategy
- Experience contributing to an oncology IND and NDA/BLA is preferred
- A Master’s degree in a scientific discipline is required, and a terminal degree (MD or PhD) is preferred
- A minimum of 10 years Regulatory Affairs experience
- Regulatory affairs certification (RAC) is a plus
- Critical Skills:
- Significant management and leadership experience required
- In-depth understanding of regulatory strategy for developing drugs and biologics
- Familiarity with the workings of regulatory agencies
- In-depth and current understanding of regulations governing drug development
- Strategic problem-solving skills and excellent organizational and multitasking abilities
- A team player with superior communication skills and proficiency in German is a plus
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 free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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