Regulatory Affairs Director

1 day ago

Cambridge, Massachusetts, United States Lifelancer Full time
Job Title: Director/Senior Director, Regulatory Affairs

About the Role:

Cullinan Therapeutics, Inc. 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.

Key Responsibilities:

  • Develop and implement global regulatory strategies for development programs, in line with business objectives and in coordination with key stakeholders.
  • 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.

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.

About Lifelancer:

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

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