Requirements:

• 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

• 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 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:

• 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.

Job Type: Full-time
Pay: $210,000.00 - $250,000.00 per year

Ability to Commute:

• Boston, MA 02210 (Required)

Ability to Relocate:

• Boston, MA 02210: Relocate before starting work (Required)

Work Location: Hybrid remote in Boston, MA 0221