Director/Sr. Director, Regulatory Strategy

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 (<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 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%)