Retained Search
We have been retained for a newly created Vice President, Global Regulatory Affairs position. This role will be leading my client’s development programs focused on cancer immunotherapy.
Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients by designing and delivering cell therapies. They are breaking new ground with science and technology, making now a perfect time to join their incredibly collaborative and patient-focused team.
Role: The Vice-President, Global Regulatory Affairs provides strategic and operational leadership to support product development across the organization. In this role, you will lead interactions with global regulatory agencies, coordinate with internal senior stakeholders, and manage and direct all regulatory strategic and operational initiatives.
Responsibilities:
- Provide global regulatory leadership supporting the global development, registration, and life-cycle management of programs.
- Responsible for oversight of the health agency meetings (FDA, EMA, etc.) and strategic planning.
- Proactively participate in the design of US and ex-US regulatory strategies for the development of cell therapy products for oncology.
- Supervise the work of all Regulatory Affairs team members, both internal, and external and manage external vendors supporting the Regulatory Affairs function.
- Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
- Oversees regulatory staff and participates in skill development, coaching, and performance feedback of regulatory staff.
- Drive adherence to regulatory requirements and guidelines.
- Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
- Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes and proactively contribute to the company compliance initiatives.
- Proactively forecast and manage the budget for Regulatory Affairs.
- Represent the company at appropriate regulatory and scientific conferences.
- Perform regulatory intelligence activities – monitor regulatory changes and competitor trends/strategies.
Qualifications & Experience:
- Experience in cell and gene therapy and/or oncology.
- Bachelor’s Degree preferably in science-related discipline, Advanced Degree preferred.
- At least 15-20 years of Global Regulatory Affairs experience.
- Track record of leading regulatory activities for development program(s).
- Experience with successful marketing applications (BLAs/NDAs/MAAs).
- Proven leadership and management experience of regulatory staff.
- Experience leading regulatory interactions, including formal meetings.
- Experience working in a matrix team environment.
- Familiarity with in-vitro diagnostic device regulations.
- Well-versed in regulatory strategy and regulatory science writing.
- Extensive knowledge in ICH, FDA, EMA, and international regulations/guidelines, including those related to cell and gene therapy.
- Companion diagnostic experience (IDE, PMA) preferred.
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Job Features
Job Category | Global Regulatory Affairs, Regulatory Affairs Oncology |
Reference Number | 201118 |