Summary of Position:The Associate Director, Regulatory Strategy, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or pipeline programs. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence to the appropriate regulatory agencies.
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%)
$175,000 - $225,000 a year
