Senior Director, Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the primary liaison for Health Authorities.

• Transform program regulatory strategy into detailed interaction plans, submission schedules, timelines, and cross-functional deliverables for clinical-stage radiopharmaceutical initiatives.

• Lead the preparation, coordination, and submission of regulatory documents, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle-related submissions.

• Organize and manage meeting rehearsals prior to interactions with Health Authorities.

• Finalize meeting notes with Health Authorities, address information requests, and track follow-up actions.

• Oversee the publishing process and submissions.

• Collaborate with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other stakeholders to create content, address data gaps, and maintain a consistent submission narrative.

• Keep records of correspondence, commitments, decisions, and submission history.

• Develop and maintain regulatory plans, workflows, submission calendars, trackers, and archives.

• Coordinate regulatory medical writing across various functions and articulate research and development data and strategies into clear, compliant regulatory communications and high-quality submission documents.

⛳️ Requirements

• A Bachelor’s degree in a scientific, medical, pharmacy, or related field is essential; an advanced degree is preferred.

• Over 12 years of progressive experience in regulatory affairs within the biotech or pharmaceutical sector.

• Proven leadership in regulatory deliverables for pre-IND to Phase 3 investigational oncology programs.

• In-depth knowledge of US FDA regulations and interaction protocols.

• Demonstrated success in coordinating US INDs, IND amendments, annual reports, health authority meeting materials, and responses to US FDA information requests.

• Practical experience with electronic submission publishing, document management, submission standards, and external publishing partners.

• Experience in leading the submission of New Drug Applications and Marketing Authorization Applications is advantageous.

• Familiarity with radiopharmaceutical development is a plus.

• Exceptional communication skills with strong scientific judgment and excellent writing and editing abilities.

• Highly organized, proactive, and detail-oriented, with a disciplined approach to following through on commitments and timelines.

• Ability to thrive in a fast-paced biotech environment with changing priorities and multiple stakeholders.

• Collaborative leadership skills, capable of aligning subject matter experts, constructively challenging ideas, and driving decision-making.

• Strong commitment to quality, compliance, and patient safety.

🏝️ Benefits

• A unique opportunity to contribute to groundbreaking cancer therapies.

• Exposure to both radiochemistry and CMC development in a vibrant biotech environment.

• Opportunities for hands-on training and professional growth.

• An international, collaborative, and supportive workplace culture.

• Competitive salary and benefits package.