- 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
- Works with the Head of Regulatory Affairs, 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
- 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 experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
- Experience supporting clinical development teams in the autoimmune disease space is a must
- Experience in Oncology and Immuno-oncology is preferred but not required
- 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
- 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
- Proven expertise in competitive and regulatory intelligence, with a keen ability to anticipate trends and navigate complex regulatory landscapes
- Demonstrated success in interacting with regional Health Authorities (HAs), with specific experience in [Asia-Pacific region].
- 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
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Senior Director, Clinical Regulatory Affairs - Waltham, United States - Dragonfly Therapeutics
Description
Senior Director, Regulatory AffairsDragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects, and to lead interactions with regulatory 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 assigned program(s), encompassing overall regulatory responsibilities.
Internally, this position will collaborate with the development team to innovate regulatory approaches and foster best regulatory practices. They 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, non-clinical, and clinical development teams. The successful candidate must demonstrate the ability to work independently and effectively manage external vendors.
Responsibilities:
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
