Director of Regulatory Affairs

Our client is a well-funded, clinical-stage biotechnology company advancing a robust pipeline of novel oncology therapies, including antibody-drug conjugates (ADCs), bispecific antibodies, multispecific antibodies, and T-cell engager technologies. With multiple clinical programs spanning early and late-stage development and an expanding global footprint, they are seeking an experienced Regulatory Affairs leader to shape worldwide regulatory strategy and accelerate the development of breakthrough cancer therapies. This is a highly visible leadership position with the opportunity to influence global regulatory strategy across multiple development programs while partnering directly with executive leadership and cross-functional teams. What You’ll Do As a senior member of the Regulatory Affairs organization, you will: Develop and execute global regulatory strategies for innovative oncology programs from early development through commercialization. Lead regulatory interactions with global health authorities including FDA, EMA, PMDA, and NMPA. Drive preparation for Health Authority meetings, briefing books, and regulatory correspondence. Lead the preparation and submission of INDs, CTAs, BLAs, annual reports, orphan drug applications, investigator brochures, amendments, and related global regulatory filings. Partner closely with Clinical Development, Medical Affairs, Nonclinical, CMC, Biometrics, and Executive Leadership to support development strategy. Provide regulatory guidance throughout product development while ensuring alignment with evolving global regulations and ICH guidance. Support regulatory agency questions, commitments, inspections, and post-submission activities. Mentor and influence cross-functional teams while serving as both a strategic leader and hands‑on contributor when needed. What We’re Looking For Ideal candidates will possess: PhD, PharmD, MD, or other advanced scientific degree Progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry Extensive experience developing global regulatory strategy for oncology therapeutics Proven experience leading FDA interactions and global Health Authority communications Experience with IND, CTA, and/or BLA submissions Strong understanding of FDA, EMA, ICH, PMDA, and global regulatory requirements Excellent scientific communication and cross‑functional leadership skills Highly Preferred Experience Bispecific or multispecific antibodies Biologics Successful BLA and/or MAA submissions Orphan Drug Designation Breakthrough Therapy or Accelerated Approval pathways Experience working with international development partners, including China This is an opportunity to join a rapidly growing biotechnology company where Regulatory Affairs is viewed as a strategic business partner rather than simply a support function. You’ll have the chance to: Work alongside an experienced executive leadership team Contribute to therapies designed to improve outcomes for patients with serious cancers Grow within an organization investing heavily in its pipeline and future Compensation Annual Bonus Equity Opportunity Interested in learning more? If you have experience leading global regulatory strategy for oncology or biologic products and would like to explore this confidential opportunity, we'd welcome a confidential conversation. Even if your background doesn't align perfectly with every requirement, we encourage you to reach out to discuss your experience. #J-18808-Ljbffr