Head of Clinical Regulatory Affairs

Head of Regulatory Affairs

Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience,  and reporting directly to the COO, to lead  our Regulatory Affairs organization. The primary responsibility of this role is to lead the development of comprehensive regulatory strategies for biologics in early Phase clinical development based on sound Regulatory Intelligence that allow for productive interactions with global competent health  authorities. This includes preparing for agency meetings and overseeing regulatory submissions such as briefing documents, IND, and CTA applications. Additionally, the incumbent will serve as the global regulatory lead for programs in oncology and autoimmune disease, encompassing overall regulatory responsibilities.

Internally, this position will collaborate with the development team to develop innovative regulatory approaches and foster best regulatory practices. This position will lead the regulatory sub-team, provide regulatory guidance to product development team members, and act as the regulatory lead on cross-functional program teams. Alignment with all stakeholders, including senior management, is crucial. This role combines strategic and operational elements and operates within a matrix environment, requiring extensive collaboration with research and clinical development teams. The successful candidate must demonstrate the ability to work independently and effectively manage external vendors.

Responsibilities (including but not limited to):

• Designs and implements regulatory strategies to obtain and maintain clinical trial applications.
• 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 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 junior staff at the company.
• Leads, participates and contributes to initiatives and activities to help build a robust high performing regulatory affairs organization including operational excellence for effective and efficient execution.
• Identifies, engages and collaborates with external regulatory experts and consultants.

Requirements:

• Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA).
• 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, with expertise to independently present complex information to 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.

Experience:

• 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.
• Advanced knowledge and experience with the drug development process, laws and regulations affecting the pharmaceutical industry in key jurisdictions, particularly US, Europe, and APAC region
• Minimum 10 years of experience in the biopharmaceutical industry and 7 years of direct experience in a regulatory strategy role working with recombinant products.
• Experience in Oncology and Immuno-oncology is required and experience in the autoimmune disease space is preferred.
• Proven expertise in competitive and regulatory intelligence, with a keen ability to anticipate trends and navigate complex regulatory landscapes.
• Strong track record of implementing innovative regulatory approaches to achieve regulatory milestones and business objectives.
• Experience in working on cross-functional teams, providing regulatory subject matter guidance.