Cullinan Therapeutics · 11 hours ago

Sr. Manager/Associate Director, Regulatory Affairs

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

5+ years exp

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Responsibilities

Serve as the Sponsor point-of-contact to regulatory bodies and/or external regulatory consultants or CRO regulatory representatives, as required.

In alignment with the global regulatory team, plan and manage regulatory activities related to assigned projects that encompass technical areas including clinical, non-clinical, and CMC.

Devise and implement regulatory strategies for clinical trial applications/amendments, responses to health authority queries, and health authority interactions in partnership with cross-functional stakeholders.

Manage high-quality and on-time regulatory submissions (e.g., IND/CTA/NDA/MAA, as applicable) in compliance with applicable regulatory requirements.

Maintain current knowledge of the product development framework and regulations to advise product teams and stakeholders.

Proactively communicate potential regulatory issues and mitigation strategies by facilitating and/or contributing to risk assessments and managing critical issues.

Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial / marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.

Actively lead or participate in regulatory department infrastructure and capability building, including best practices, templates, training tools, and cross-program knowledge sharing.

Qualification

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Regulatory Affairs experienceDrug development processRegulatory submission strategiesBiological/physical sciences degreeDocument managementRegulatory Information Management (RIM)Veeva Vault experienceMS Office proficiency

Required

BA/BS degree in biological/physical sciences required.

5+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience.

Strong understanding of the drug development process, pharmaceutical regulatory requirements, healthcare environment and policy.

Strong written and oral communication and organizational skills, including ability to prioritize work tasks across multiple projects and timelines.

Ability to comprehend complex scientific information and regulatory guidelines, and formulate recommendations based on assessment.

Demonstrated ability to effectively work independently (with limited oversight) and/or collaboratively with pragmatism while navigating stressful situations and diverse stakeholders.

Experience effectively leading regulatory submissions and interactions in a fast-paced, matrixed environment.

Experience with document management and Regulatory Information Management (RIM).

Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks.

Strong problem-solving skills and attention to detail.