Executive Director, Regulatory Liaison

Job Description

The Executive Director, Companion Diagnostics/ In Vitro Diagnostics, reporting to Vice President, Global Regulatory Affairs and Clinical Safety (GRACS) Oncology Therapeutic Area, is responsible for overseeing the development and implementation of worldwide regulatory strategy for Companion Diagnostics/In Vitro Diagnostic projects within their portfolio. The individual functions with a high degree of independence and provides oversight for assigned products. They directly manage a team of regulatory strategists and are recognized as an expert in Companion Diagnostics/In Vitro Diagnostic development and they provide technical and professional leadership to staff handling multiple projects. Their subject matter expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. They are also a recognized internal expert for one or more aspects of regulatory policy or geographic regions.

Primary Responsibilities: 

• Effectively communicate to (and manage) multiple senior stakeholders in our Research and Development (R&D) Division and Global Human Health (GHH) to bring an awareness of the product/program risks. Collaborate and work effectively across boundaries to enable the timely (proactive) resolution. Demonstrate leadership capabilities to drive an effective conversation at senior levels.

• Oversight and management of regulatory strategists including review of regulatory strategy for respective products as needed.

• Lead complex programs or components thereof of significant value to the company.

• Apply high-level scientific judgment in a variety of highly complex and unprecedented situations

• Review and approve regulatory submissions.

• Review and approve communication materials to be used external to our Company such as press releases for accuracy and consistency of message.

• Review and approve background packages to ensure clarity and comprehensive presentation of issues.

• Review labeling and manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet.

• Participate in regulatory due diligence activities for licensing candidate review.

• Manage assignments for their regulatory liaisons, including resourcing for project assignments.

• Provide technical and professional leadership to staff and conduct all appropriate HR activities such as managing performance, development planning; staffing and related people-management responsibilities for regulatory liaisons within areas of responsibility.

• Develop relationship with external stakeholders (industry and regulators) to understand the current landscape and influence internally to implement rigorous, innovative and science-based approaches to our development and submissions.

• Represent our Company as needed at external initiatives notably with regulatory authorities.

Education Requirement:

• Required: B.S. or M.S. with a minimum of 12 years relevant drug development experience, a majority of which was in Regulatory OR M.D. or PhD or PharmD with a minimum of 7 years relevant drug development experience preferably with 5 years in Regulatory.

• Preferred: M.D. or PhD in biological science, chemistry or related discipline.

Required Experience and Skills:

• Companion Diagnostics/In Vitro Diagnostics regulatory experience required.

• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.  

• Outstanding interpersonal, communication and negotiation skills.

• Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

Preferred Experience and Skills:

• Prior people management experience.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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