Senior Director Regulatory Affairs
About the Role
We are seeking a highly experienced regulatory affairs leader to join a clinical-stage biotechnology company developing novel oncology therapeutics. This is a strategic role responsible for shaping global regulatory strategies and guiding programs through early and late-stage development.
Key Responsibilities
- Lead global regulatory strategy for multiple oncology programs, including antibody-drug conjugates and biologics.
- Oversee preparation and submission of INDs, CTAs, and BLAs, ensuring compliance with FDA, EMA, and other health authority requirements.
- Serve as primary regulatory liaison for internal teams and external stakeholders, including health authorities.
- Advise cross-functional teams on regulatory requirements for CMC, nonclinical, and clinical development.
- Develop regulatory processes and systems to support company growth and future filings.
- Monitor evolving regulations in oncology and biologics to inform strategic decisions.
- Manage regulatory interactions, including pre-IND meetings and scientific advice procedures.
Qualifications
- Advanced degree in life sciences or related field (PhD, PharmD, or MS preferred).
- 10+ years of regulatory affairs experience in biotechnology or pharmaceutical industry.
- Proven track record in IND/CTA submissions and global regulatory strategy.
- Experience in oncology biologics or antibody-drug conjugates strongly preferred.
- Ability to thrive in a fast-paced, collaborative environment.
- Strong leadership, communication, and problem-solving skills.
Why Join Us
- Opportunity to shape regulatory strategy for innovative oncology programs.
- Work on transformative therapies addressing high unmet medical needs.
- Collaborative, mission-driven culture with significant growth potential.
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