Job details

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.

Position 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.

Candidate Requirements:

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.

Average salary estimate

$125000 / YEARLY (est.)

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$100000K

$150000K

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What You Should Know About Sr. Manager/Associate Director, Regulatory Affairs, Cullinan Therapeutics

At Cullinan Therapeutics, Inc., we are at the forefront of biopharmaceutical innovation, passionately dedicated to pushing the limits of medical care for patients. As a Senior Manager/Associate Director of Regulatory Affairs, you'll have the unique opportunity to be an integral part of our mission. In this role, you’ll represent our global regulatory interests on cross-functional teams, ensuring our clinical-stage assets move efficiently through the regulatory landscape. You will be pivotal in creating and executing regulatory submission strategies that comply with various national regulations. Your expertise in regulatory frameworks will allow you to develop and review submission components and craft thorough health authority briefing packages. It’s not just about submissions; you'll also identify potential regulatory challenges and devise actionable strategies to mitigate risks. Collaborating across teams, you'll be the bridge that keeps our projects aligned with regulatory expectations—and you’ll be doing this while contributing to ground-breaking oncology and autoimmune therapies. We are looking for someone who can thrive in a fast-paced environment, manage multiple projects seamlessly, and communicate complex scientific information in a clear and concise manner. If you are passionate about regulatory affairs and want to be part of a company that is committed to changing lives through innovative therapeutics, then joining Cullinan Therapeutics as a Senior Manager/Associate Director of Regulatory Affairs could be the right fit for you.

Frequently Asked Questions (FAQs) for Sr. Manager/Associate Director, Regulatory Affairs Role at Cullinan Therapeutics

What are the key responsibilities of a Senior Manager/Associate Director at Cullinan Therapeutics?

The Senior Manager/Associate Director, Regulatory Affairs at Cullinan Therapeutics is responsible for serving as the global regulatory representative on cross-functional development teams, devising regulatory strategies, managing high-quality submissions (like IND/CTA/NDA/MAA), and providing guidance on regulatory requirements. This role involves proactive communication with stakeholders and regulatory bodies to navigate potential issues and ensure the smooth passage of our clinical assets through the regulatory landscape.