Competitive- Above Market Average
about 1 month ago
Clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. Committed to patients with cancers harboring mutations in the RAS signaling pathway.
- 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.
- Manage relationship with external consultants/CROs supporting development of study start up activities.
- Effectively plan, organize, and conduct, in close collaboration with cross-functional team members, formal meetings with health authorities.
- Maintains up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
- Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements
Education and Skills Required:
- 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.
- A strategic as well as an operational approach with the ability to "think outside the box" and to manage multiple tasks in a fast-paced environment.
- Some travel required.
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Jessica FIgueroa 619-326-3672 or firstname.lastname@example.org