Executive Director, Regulatory Affairs

Beeline Medicines • Boston, MA

9d • Hybrid

About The Position

The Executive Director, Regulatory Affairs will report to the Senior Vice President, Regulatory Affairs & Quality and serve as the Global Regulatory Lead to provide global regulatory strategy and leadership for assigned programs. This role will be responsible for the development and execution of global regulatory strategy for the product, ensuring timely preparation, review and submission of IND/CTA/NDA/MAA and other Marketing Applications to regulatory authorities globally, and ensuring compliance with applicable regulatory requirements. In addition, this role will be responsible for maintaining any future marketing approvals globally and developing and implementing strategies for indication expansion in collaboration with cross functional program teams. The incumbent will manage contractors/consultants globally, possibly lead direct reports in the future, represent the function on multi-disciplinary teams, and must integrate company goals into the objectives and activities of the Regulatory Affairs Department. This individual must be highly proactive, execution-oriented, collaborative, and able to maintain strong alignment with the Senior Vice President, Regulatory Affairs & Quality while taking clear ownership of assigned programs.

Requirements

• Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.
• Minimum of 15+ years of Regulatory Affairs experience in pharmaceutical and/or biotechnology industry with at least 5 years as Global Regulatory Lead (GRL)
• Hands-on experience with CTA submissions, NDA submissions, MAAs, briefing books, and health authority responses required.
• Experience in effective negotiations with FDA and EMA and other global health authorities (e.g., FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Demonstrated track record of leading marketing applications globally, from submission to approval and indication postmarketing maintenance
• Experience with investigational drugs, including early and late-stage development, and marketed products
• Balances strategic oversight with active involvement in execution and willingness to roll up their sleeves and contribute directly.
• Demonstrates an entrepreneurial, self-driven mindset, proactively solving problems and anticipating needs, while exercising strong business acumen to keep leadership appropriately informed and engaged
• Proactively identifies issues and drives resolution, using sound judgment to remove obstacles and maintain momentum
• Independent but collaborative; able to take ownership without operating as a lone ranger.
• Demonstrated ability to coach, mentor, and develop direct reports as well as other members of Regulatory team
• Communicates clearly and concisely, providing unambiguous direction to teams and stakeholders
• Translates complexity into clear priorities and actionable plans, enabling efficient execution across multiple workstreams
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment

Nice To Haves

• Immunology experience highly preferred.

Responsibilities

• Develop Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings
• Direct and coordinate the regulatory strategy and execution of assigned projects, including INDs, CTAs, NDAs, MAAs, briefing books, health authority responses, lifecycle management, and indication expansion.
• Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies; communicate clear, concise, project updates and recommendations to senior leadership
• Lead global regulatory submissions, lifecycle management and regulatory health authority interactions to support the conduct of clinical trials and approval of marketing applications throughout the lifecycle of assigned projects
• Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
• Manage regulatory timelines, deliverables, documents, contractors/consultants, and future direct reports, ensuring work is accurate, complete, verifiable, and completed with urgency and accountability.
• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
• Supervise, analyze, and disseminate intelligence on matters that may affect ongoing development programs
• Monitor, interpret, and apply evolving regulations, guidance, and regulatory intelligence to assigned programs while collaborating closely with cross-functional partners to enable successful program outcomes.
• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and collaborate with regulatory authorities; be primary liaison for day-to-day interactions
• Perform other duties and responsibilities as assigned.

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Executive