Director/Sr. Director, Regulatory Affairs

About the jobCullinan 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 Director/Senior Director, Regulatory Affairs, 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 key regulatory team member with responsibility for providing strategic and operational regulatory direction and support on projects including, but not limited to, overall regulatory strategies, regulatory requirements for clinical studies, regulatory strategic development plans and risk assessments, critical issue management and leadership of health authority interactions.
• Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development.
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals.
• Act as the primary liaison with regulatory authorities.
• Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with global requirements.
• Support due diligence and partnering activities, as needed.
• Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape.
• Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Responsible for assisting with the development and implementation of regulatory processes.
• Recruits, develops, manages, and mentors regulatory professionals and helps create a supportive and growth-minded culture.
• Perform all duties in keeping with the Companys core values, policies and all applicable regulations.
  
  

Candidate Requirements

• 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
• Thorough understanding of drug development process, pharmaceutical industry, regulatory requirements, healthcare environment and policy
• Extensive experience with INDs/CTAs, product development, development of regulatory strategies with a proven track record of significant regulatory accomplishments
• Able to provide regulatory leadership and guidance on cross-functional teams and work in a matrixed environment.
• Demonstrates expertise in developing and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.
• Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents.
• A business leader, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
• Ability to articulate the organizations strategic vision and core values, and successfully contribute to improving the quality of internal department and business policies, programs, and initiatives.

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