Sr. Director Asset Regulatory Affairs Lead

Role Summary

Sr. Director Asset Regulatory Affairs Lead leading regulatory strategy for a late-stage asset, preparing for its first global marketing application, and partnering across disciplines to enable timely filings and successful product launches. Remote-friendly with potential locations near Boston, Belgium, or Switzerland.

Responsibilities

• Provide strategic, operational and tactical regulatory insight on global activities for assigned programs, focusing on accelerating development and availability to patients.
• Offer strategic regulatory guidance for assigned compound, guide filing strategies in primary regions, and coordinate across disciplines for timely filings.
• Articulate global regulatory strategy to senior management.
• Partner with asset teams to ensure timely regulatory input to business decisions.
• Ensure coordinated regulatory strategy across regulatory leads on indication development teams, asset team, and broader regulatory group.
• Collaborate with asset teams, IDTs and PMO/Reg PM staff to plan global submission timelines and align regulatory strategies with organizational goals.
• Oversee and mentor the regulatory team.

Qualifications

• Minimum 15 years of regulatory affairs experience in biopharmaceuticals, with 5‚Äì7 years in global leadership roles driving regulatory strategies for submissions and launches.
• PhD or PharmD preferred.
• Experience in therapeutics for autoimmune neurology, renal, or rheumatology conditions preferred.
• Experience in rapidly growing pharmaceutical organizations desirable.
• Understanding of biologic drug development and licensure for orphan and pediatric indications; knowledge of evolving regulations and guidelines.
• Ability to coordinate critical regulatory documents for FDA, EMA, and PMDA submissions.
• Strong scientific background with ability to interact with scientists and clinicians.
• Effective communication with diverse stakeholders; strong presentation, written, and verbal skills.
• Track record of interactions with regulatory and health authorities.
• Ability to build relationships across the organization to achieve goals; thrive in a fast-paced, accountable environment.
• Pragmatic, creative, and collaborative leadership; ability to lead teams and execute strategically.

Skills

• Regulatory strategy, submission planning, and lifecycle management
• Global regulatory landscape knowledge (FDA, EMA, PMDA)
• Cross-functional leadership and stakeholder management
• Project management and organizational skills
• Scientific communication and diplomacy

Education

• PhD or PharmD preferred

Additional Requirements

• Role can be based remotely near Boston, Belgium, or Switzerland.