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Tubulis GmbH · 2 days ago

Associate Director/Director, Global Regulatory Affairs Strategy

Greater Boston

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

Tubulis, Inc. is a clinical stage biotech company focused on developing innovative antibody-drug conjugates for cancer treatment. The Associate Director/Director of Global Regulatory Affairs Strategy will provide regulatory strategy support, manage regulatory aspects of clinical trials, and ensure compliance with global health authority requirements.

BiotechnologyHealth CareLife SciencePharmaceuticalTherapeutics

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

Qualification

Regulatory Affairs StrategyClinical Trial ApplicationsGlobal Regulatory RequirementsOncology ExperienceLate-stage Development ExperienceOrganizational SkillsCommunication SkillsProblem-solving SkillsCollaboration Skills