Retained Search

Our client has retained us to fill a VP of Clinical Regulatory Position. In this hands-on role, you will lead the Clinical Development and Regulatory Affairs practice while being responsible for client engagements, leadership, and operational direction on all clinical and regulatory projects.

Organization: My client is a scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:

• Develops clinical and regulatory strategies for clients.
• Provide global regulatory leadership supporting the global development, registration, and life-cycle management of programs.
• Provides strategic clinical and regulatory leadership.
• Facilitates and leads communications with agencies.
• Prepares and reviews regulatory documents for submission to FDA; oversees critical deliverables.
• Partners and collaborates with the company’s senior management team to ensure strategic business goals are met by sharing knowledge and expertise.
• Responsible for oversight of the health agency meetings (FDA, EMA, etc.) and strategic planning.
• Share knowledge and provides guidance and information on emerging trends, regulations, and industry guidelines to develop accurate regulatory strategies.
• Represent the company at appropriate regulatory and scientific conferences.
• Provides counsel, training, and interpretation of FDA and other regulatory issues to staff and clients.
• Leads and mentors staff on clinical and regulatory strategies.
• Builds, leads, and manages a team of regulatory professionals by enhancing a culture where the staff is supported, growing in their capabilities, and performing to their highest level.
• Ensures clients’ goals and expectations are met.

Knowledge and Skills:

• A science degree (four-year degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science is required. An advanced degree in a related field is preferred (MS, PhD or MD, DVM).
• Minimum 15 years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry or equivalent.
• Minimum 10 years experience developing, leading, managing, and growing a high-performing regulatory affair team.
• 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 in leading negotiations and facilitating the resolution of issues with regulatory agencies, of interest USA FDA, with positive outcomes.
• Experience in a scientific or regulatory consulting firm is a plus.

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