Associate Director, Regulatory Strategy

Position Responsibilities

• Serve as a thought leader on regulatory affairs, defining regulatory strategy and plan to maximize regulatory success in our next generation anti-myostatin therapy and US regulatory representative for new indication for an approved product.
• Regulatory representative on cross-functional teams to ensure compliance with regulations
• Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements
• Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
• Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
• Regulatory intelligence gathering, synthesizing and communicating to stakeholders., relevant
• Identify regulatory risks and opportunities and work with key stakeholders to develop solutions/risk mitigations
• Conduct regulatory research to help inform development strategies
• Manage the Clinicaltrials.gov disclosure for programs across the portfolio.
• Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Candidate Requirements

• Education in life sciences required
• Located in the greater Boston area required
• 5+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
• Demonstrated experience of leading successful engagement with key regulatory agencies (
• Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
• Strong written, verbal communication skills, and interpersonal skills
• Capable of managing shifting priorities in a rapidly changing and environment
• Ability to travel domestically and internationally (~10%)