Remote: Vice President Regulatory Affairs

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Remote

Our client is a clinical-stage biopharmaceutical company focused on discovering and developing small-molecule kinase inhibitors to address existing and emerging unmet needs in oncology. With a precision oncology approach, their focus is to improve survival and enhance the overall well-being of cancer patients.

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:

• Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations.
• Provide global regulatory leadership supporting global development.
• Collaborates effectively with cross-functional teams and contract research organizations, clearly defining regulatory expectations.
• Supports and organizes preparations for Health Authoring meetings and teleconferences.
• Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC), and labeling).
• Prepares and coordinates regulatory submissions (ie, clinical trial applications, formal meeting documentation, submissions, etc.); supports preparations and submission of INDs and marketing applications, as applicable.
• Acts as the regulatory representative on early and late phase clinical studies, ensuring regulatory compliance and guidance.
• Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
• Guides and executes regulatory strategy for long-term development planning, including the potential to accommodate expedited development needs.
• Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
• Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
• Represent the company at appropriate regulatory and scientific conferences.
• Ensure adherence to current regulations associated with regulatory activities.
• Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.

Qualifications & Experience:

• Must thrive working in a rapidly moving, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
• Hands-on professional able to execute regulatory submissions and operations to achieve corporate goals.
• Track record of leading global regulatory activities for development program(s).
• Demonstrated success in Small Molecule, Phase 1, Oncology programs Required.
• Must be able to solicit information, persuade others, and shape outcomes.
• At least 15 years of Global Regulatory Affairs leadership experience.
• Well-versed in regulatory strategy and regulatory science writing.
• Significant experience or equivalent of delivering positive global outcomes, across a portfolio of products, on programs varying in scientific & clinical complexity.
• Bachelor’s Degree in science-related discipline, Advanced Degree preferred.