Position located in Boston, MA

Responsibilities of the Director of Regulatory Affairs (Biologics):

• Oversee global regulatory strategies and regulatory submissions including INDs, CTAs, BLAs, and MAAs.
• Will lead Regulatory Team’s strategy and oversee the team’s activities from IND-enabling studies.
• This highly visible leadership role is responsible for developing and executing regulatory strategy, ensuring regulatory compliance across early-stage development, and optimizing global health authority interactions.
• Collaborate cross-functionally with internal teams and align regulatory strategies with affiliate and parent organizations.
• Act independently under the direction of the supervisor to effectuate the Regulatory strategy in the form of writing, preparing and filing regulatory documents on-time and successfully.
• Organize, plan and prepare global regulatory product strategies and submission packages for assigned products and any subsequent responses to inquiries by regulatory agencies.
• Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders.

Requirements of the Director of Regulatory Affairs (Biologics):

• Advanced degree in a relevant field (PhD, PharmD, MS, or equivalent).
• 10+ years of regulatory affairs experience, including at least 5+ years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC) and global compliance.
• Strong knowledge of FDA, EMA, PMDA, and ICH regulatory requirements for biologics and advanced therapeutics.
• Strong communication and proactive negotiation skills. Business acumen and able to work under pressure.