Sr. Director, Regulatory Strategist
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
This Senior Director level position, reporting to Senior Vice President, Head of Regulatory Affairs, will be a member of the regulatory team within the Regulatory Affairs organization, responsible for the development of non-clinical and clinical regulatory strategies and lead the interactions with the regulatory authority, FDA, in US and the preparation of agency meetings and regulatory submissions, including, but not limited to, briefing documents, IND and BLA. In addition, the individual may also serve as the global regulatory lead for the assigned program(s) with the overall regulatory responsibilities for a specific program.
Internally, this role will work with the development team to develop innovative regulatory approach, best regulatory practice, lead the regulatory sub-team, interact cross-functionally with product development team members to provide regulatory guidance, serve as the regulatory lead on cross-functional program team, and align with all stakeholders including senior management. This role is both strategic and operational, will operate in a matrix environment including extensive collaboration with research, non-clinical and clinical development. This role will require both the capacity to work independently, as well as to manage external vendors.
- Designs and implements regulatory strategies to obtain, maintain and extend product registrations.
- Provides regulatory guidance and input to project teams.
- Oversees the creation and submission of all regulatory filings within scope of responsibility.
- Serves as corporate liaison with regulatory agencies to develop effective professional relationships as well as our positive company image.
- Provides guidance to all appropriate departments in Centessa to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
- Arranges for and leads meetings with global health authorities as needed.
- Provides training and mentorship to regulatory staff and other Centessa staff.
- Work with the Head of Regulatory Affairs, lead, participate and contribute to initiatives and activities to help build a robust high performing regulatory affairs organization including operational excellence for effective and efficient execution.
- Identify, engage and collaborate with external regulatory experts and consultants.
- Expertise in regulatory submission structure and content (e.g. MAA, NDA, BLA, IND, CTA, NDS).
- Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies.
- Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals.
- Extensive understanding of requirements for regulatory submissions, including IND or BLA. Excellent written and oral communication skills Expertise to independently present complex information to Centessa senior management, consultants, regulatory authorities and the medical community.
- Demonstrated ability to blend analytical critical thinking, problem-solving, organizational and negotiation / decision-making skills to enable scientific data-driven, regulatory compliant narratives of regulatory documents.
- Expertise to write scientific and technical documents.
- Demonstrated ability to work in an innovative and fast-paced environment.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Bachelor's degree in Life Sciences or related fields required; advanced degrees such as PhD in biomedical sciences or related fields preferred. A degree in regulatory disciplines or Regulatory Affairs Certification (RAC) certification is a plus but not required.
- Minimum 10 years of post-undergraduate experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required.
- Experience in working on cross-functional teams, providing regulatory subject matter guidance.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.