Vice President, Head of Regulatory Strategy

Position Responsibilities

Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success across the portfolio.
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 (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.
Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)
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 document
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
• 15+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of US/EU regulatory requirements
• Demonstrated experience of leading successful engagement with FDA and 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 (~20%)