Summary of Position:The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and implementation of the Global Strategy for assigned clinical and/or pipeline programs globally depending on the program. 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.
Position Responsibilities- Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success.
- Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (
- Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (
- Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
- Lead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authorities
- Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., Module 1, briefing documents)
- Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
- Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
- Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
- Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan
- Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)
- Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
- Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
- Provide support to local regulatory experts
- Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed
Candidate Requirements- Education in life sciences required
- Greater Boston-based with ability to be regularly present in the Cambridge, MA office
- 7+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of EU regulatory requirements
- Demonstrated experience of leading successful engagement with EMA
- 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%)
$200,000 - $300,000 a year
