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Senior Director, Regulatory Affairs
Dragonfly 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:
Qualifications:
Full Time
Scientific Services
$170k-225k (estimate)
03/30/2024
05/16/2024
dragonflytx.com
CAMBRIDGE, MA
100 - 200
2015
BILL HANEY
<$5M
Scientific Services