Sr. Manager/Associate Director, Regulatory Affairs Full Time

Summary:

• Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients.
• The company has a diversified portfolio of clinical-stage assets focused on inhibiting key disease drivers or harnessing the immune system to eliminate diseased cells in oncology and autoimmune diseases.
• With expertise in oncology, immunology, and translational medicine, Cullinan Therapeutics develops differentiated therapeutic solutions across a wide variety of cancer and autoimmune indications.
• The Senior Manager/Associate Director, Regulatory Affairs will serve as the global regulatory representative on cross-functional development teams.
• Responsible for creating and executing regulatory submission strategies in compliance with national regulations.
• Will contribute to and potentially lead the authoring of health authority briefing packages and responses to health authority queries in collaboration with relevant function leads.
• The role includes providing guidance on regulatory frameworks and technical requirements to support cross-functional project development teams.

Responsibilities:

• Serve as the Sponsor point-of-contact to regulatory bodies and/or external regulatory consultants or CRO regulatory representatives.
• Plan and manage regulatory activities related to assigned projects, covering clinical, non-clinical, and CMC technical areas.
• Devise and implement regulatory strategies for clinical trial applications/amendments, responses to health authority queries, and health authority interactions in collaboration with cross-functional stakeholders.
• Manage high-quality and on-time regulatory submissions (e.g., IND/CTA/NDA/MAA) in compliance with regulatory requirements.
• Maintain current knowledge of product development frameworks and regulations to advise product teams and stakeholders.
• Proactively communicate potential regulatory issues and mitigation strategies by facilitating or contributing to risk assessments and managing critical issues.
• Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures.
• 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.

Requirements:

• BA/BS degree in biological/physical sciences required; advanced degrees preferred.
• 5+ years of 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 the ability to prioritize 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 collaborate in a fast-paced, matrixed environment.
• Experience leading regulatory submissions and interactions.
• Experience with document management and Regulatory Information Management (RIM). Veeva Vault experience preferred.
• Proficient with MS Office tools for project management, tracking, writing, and presentation tasks.
• Strong problem-solving skills and attention to detail.

Benefits:

• Cullinan Therapeutics is an Equal Opportunity Employer.
• The company is committed to creating an inclusive and diverse environment for all employees and applicants, regardless of race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.