This is a growing & well-funded clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. They are seeking a Director of Regulatory affairs to provide leadership, clinical development strategy, and oversight of clinical science deliverables.
The Director of Regulatory Affairs will have the following specific responsibilities:
Reporting directly to the Sr. Director of Regulatory Affairs, the Director of Regulatory Affairs will provide leadership, clinical development strategy, and oversight of clinical science deliverables.
· Represent Regulatory Affairs in cross functional meetings and initiatives for assigned programs. Participate as an active, engaged team member on core projects and/or provide RA guidance/strategy to Core team members.
· Develop regulatory strategic plans in collaboration with project teams to execute strategies for regulatory submission. Generate regulatory submission plans, and direct document development, review, and finalization. Collaborate with team members to ensure agreed timelines and milestones are met.
· Independently or with limited oversight plan, lead the preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications and amendments or supplements.
· Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
· Provide technical review of clinical data relevant to regulatory submissions.
Required Experience, Skills, and Education:
· B.A./B.S. in the sciences, or health related field with a minimum of 10 years of experience working in regulatory affairs within the pharmaceutical/biotechnology industry. S/he would have experience in preparation and submission of IND/CTA/NDA/MAA submissions with the regulatory agencies, and the ability to contribute to the submission of global regulatory applications.
· Experience working on Phases 1-3 clinical trials.
· Early stage Oncology experience is required.
· Familiarity with the interpretation and application of relevant FDA guidelines pertaining to CMC, nonclinical and clinical matters in drug development.
· Experience interacting directly with the FDA and other health authorities.
· Proven ability to effectively work collaboratively in cross-functional teams and lead team discussions.