Sr. Manager/Associate Director, Regulatory Affairs

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.

We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.

Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.

We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.

With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. 

Summary:

The Senior Manager/Associate Director, Regulatory Affairs will serve as the global regulatory representative on cross-functional development teams and is responsible for the creation and execution of regulatory submission strategies across numerous countries and in compliance with national regulations. The regulatory affairs professional will develop and review submission components, contribute to (or potentially lead) authoring of health authority briefing packages and responses to health authority queries in collaboration with relevant function leads with minimal direct supervision. The individual in this role will also provide guidance and detailed interpretation of the regulatory framework and technical requirements to support cross-functional project development teams.

• 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.

• BA/BS degree in biological/physical sciences required. Advanced degrees preferred.
• 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). Veeva Vault experience preferred.  
• Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks. 
• Strong problem-solving skills and attention to detail.

Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.