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.