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Senior Director Regulatory Affairs

Company: Catalyst Life Sciences, a JCW Company
Location: Baltimore
Posted on: September 18, 2020

Job Description:

This is an opportunity for someone with a proven track record of regulatory strategy leadership to join a high growth public company in the immunology and oncology space, and have a significant impact on the strategy for upcoming submissions. With both public investment and big bio-pharma partnerships, there is a lot of hype around this organisation's future within the immuno-oncology space.Core ResponsibilitiesLead the strategy for ongoing and upcoming regulatory submissions (IND, CTAs and NDAs/BLAs) with products currently going through promising clinical trials Act as point of contact for Regulatory Agencies between US and global teams; Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders. Participate in the development and implementation of short- and long-term Regulatory plans for key projects; Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs; Lead preparations and delivery of FDA communications with Clinical Development Teams Qualifications/Education required to be consideredMinimum of a Bachelor's Degree in an applied science field. Ph.D degree is highly preferred. 10+ years' Regulatory Affairs experience in drug development and/or registration activities is a must. Must have worked in the oncology or immunology space. Proven track record of successful strategy leadership and management within a regulatory function. Please be advised that only those who do not require sponsorship are able to be considered at this point.

Keywords: Catalyst Life Sciences, a JCW Company, Baltimore , Senior Director Regulatory Affairs, Executive , Baltimore, Maryland

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