Associate Director/Director, Global Regulatory Affairs Strategy

Tubulis • Boston, MA

1d • Remote

About The Position

As the Associate Director/Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy support in partnership with cross functional teams and subject matter experts and manage regulatory aspects through all phases of development of our antibody-drug conjugates (ADCs) global clinical trials. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions. This position will report to the Senior Vice President, Regulatory Affairs within the Clinical Development department and be based in Boston, MA or possible remote opportunities within other locations within the U.S. Your mission Support the development and execution of global regulatory strategies for products and programs within the global portfolio. Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines. Prepare and coordinate high-quality regulatory global submissions, including BLAs, INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents. Support planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence. Monitor the global regulatory landscape to identify requirements, trends, and potential impact on development programs. Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams. Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions. Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency. Assist in risk assessment and mitigation planning for regulatory deliverables.

Requirements

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred.
• Minimum of 5 years in Regulatory Affairs (Strategy).
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence.
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines).
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities and work effectively in a dynamic and collaborative environment
• Demonstrated ability to work both independently and collaborate within cross-functional, matrixed teams.

Nice To Haves

• Oncology therapeutic area experience strongly preferred.
• Late-stage development regulatory experience, preferably including working on a significant submission (eg NDA or BLA, MAA) is a plus.

Responsibilities

• Support the development and execution of global regulatory strategies for products and programs within the global portfolio.
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines.
• Prepare and coordinate high-quality regulatory global submissions, including BLAs, INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents.
• Support planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence.
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on development programs.
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams.
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions.
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency.
• Assist in risk assessment and mitigation planning for regulatory deliverables.

Benefits

• Impact that matters : Contribute to breakthrough therapies.
• Global mindset : Work in an international, diverse team.
• Grow & thrive : Develop your career in a supportive, fast-moving environment.
• Innovation every day : Push boundaries with cutting-edge science.
• At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

What This Job Offers

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