Director, Regulatory Affairs Strategy - Oncology

Director Regulatory Affairs – responsibility in global regulatory activities with a focus on Clinical Regulatory filings. Provide regulatory leadership on project teams, support clinical study activities, and lead IND/CTA and BLA submissions. Typical day responsibilities Interpret regulatory authorities feedback, policies and guidelines. Lead development of regulatory strategic plans in conjunction with project teams or through reports; own preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex issues using regulatory expertise, planning, and communication to secure governmental approvals. Ensure quality and timeliness of IND/CTA and BLA submissions; interact with other functions and partners in preparation, review, and completion of documents. Plan, prioritize, supervise and/or conduct activities closely with other leads; ensure compliance with regulations and timelines. Provide interpersonal support and lead personnel. Demonstrate critical thinking, leadership, assertiveness, negotiation, and project‑management skills from past drug-development project teams. This role might be for you if Strong understanding of US FDA and international guidance, regulations, drug‑development process, and industry‑standard practices. Experience interacting with CROs in managing ex‑US/ex‑EU CTAs toward clinical trial activations (preferred). High attention to detail; ability to coordinate and prioritize projects according to company goals. Strong interpersonal skills, both written and verbal. To be considered Must possess excellent written and verbal communication skills along with an MD, Ph.D., or PharmD degree. Minimum 10 years of pharmaceutical‑industry experience, at least 7 years of regulatory experience. This role requires working onsite 4 days per week in either Warren, NJ, Tarrytown, NY, or Cambridge, MA. If not local and qualified, relocation support can be offered. Salary Range (annually) $205,000.00 - $341,600.00 Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr