Director, Regulatory Affairs

Todd & Weld, LLP; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

A leading biopharmaceutical company seeks a Regulatory Affairs Director responsible for overseeing global regulatory strategies. The role involves guiding development teams, communicating with regulatory authorities, and ensuring compliance with regulations while supporting corporate goals.

Qualifications

• 10+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry.
• Experience in autoimmune disease and/or hematology/oncology development.
• Skills in navigating regulatory challenges and influencing decision-making.

Responsibilities

• Serve as global regulatory lead for development teams.
• Analyze international and country-specific guidelines and lead regulatory submissions.
• Provide mentorship and build regulatory department capabilities.

Skills

Regulatory strategy

Regulatory guidance

Project management

Communication

Influencing decisions

Education

BA/BS degree in biological/physical sciences

Advanced degrees preferred

Tools

Veeva Vault

MS Office

Job description

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 Regulatory Affairs Director is a regulatory leader with expert technical and tactical experience in regulatory strategy and will be responsible for overseeing the development and implementation of global regulatory strategies for development programs, in line with business objectives and in coordination with key stakeholders.
The incumbent will play a major role in shaping cohesive regulatory strategy across the product portfolio and ensuring effective integration of broad regulatory ideas/tactics supporting corporate goals and product development strategies. Externally, this individual will interface with regulatory authorities and business partners regarding program development and registration strategies. This role will understand and translate regulatory, scientific, operational, and business knowledge into effective implementation plans and strategy.

Position Responsibilities:
-Serve as the global regulatory lead, who is responsible for providing strategic and operational regulatory guidance to development teams including (but not limited to) global submission plans, US/EU or other national clinical trial requirements, and health authority interaction leadership.
-Represent Cullinan as the primary point of contact for regulatory authorities and/or contracted regulatory representatives (e.g., CRO local representative).
-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.
-Lead high-quality, on-time regulatory submission execution (IND/CTA/NDA/MAA, as applicable) in compliance with applicable regulatory requirements in a fast-paced matrixed environment, and in alignment with corporate goals.
-Actively lead or participate in regulatory department infrastructure and capability building, including best practices, templates, training tools, and cross-program knowledge sharing.
-Support due diligence and strategic partnering activities, as needed.
-Provide mentorship and coaching to regulatory colleagues to foster a supportive and growth-minded culture.
-Perform duties in accordance with Cullinan’s core values, policies and all applicable regulations.

-In-depth and robust knowledge of the drug development process, pharmaceutical industry, health authority regulations, healthcare environment and policies.
-Highly skilled in the development and management of multinational IND and clinical trial applications throughout the product development lifecycle, with a proven track record of significant regulatory accomplishments.
-Ample experience leading teams in the preparation of health authority applications and health authority interactions.
-Reliable and collaborative leader, who is skilled in devising pragmatic solutions while navigating challenging situations.
-Accustomed to independently providing regulatory leadership and guidance on cross-functional teams and working in a matrixed environment.
-Well-versed in the evaluation of complex scientific information and regulatory guidelines, with a demonstrated ability to formulate recommendations based on assessment.
-Effective communication skills with a demonstrated ability to influence decision-making and/or deliver comprehensive recommendations in written or verbal presentation format.
-Possess strong scientific and business acumen, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
-BA/BS degree in biological/physical sciences required. Advanced degrees preferred.
-10+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience
-Experience in autoimmune disease and/or hematology/oncology development
-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.