Director, Regulatory Intelligence & Research

Job Description

General Summary:

The Regulatory Intelligence & Research Director provides strategic global regulatory insights to the organization. This individual leads the identification, impact assessment, and communication of timely and relevant developments in the global, external regulatory environment that impact Vertex products. This individual partners with Regulatory Strategy Team Leads and other internal stakeholders to develop tailored and targeted communications of regulatory intelligence insights, including impact assessments to inform Vertex's drug development strategies.

In addition, the Regulatory Intelligence & Research Director is responsible for carrying out custom-made expert regulatory precedent research, in line with the needs of Regulatory teams, to inform highly effective regulatory program strategies and senior level decision-making.

Key Duties and Responsibilities:

• Identify and respond to Global regulatory/legislative policy insights that impact research, development and lifecycle management of Vertex assets, stemming from a variety of external sources including competitive intelligence resources.
• Support product development strategies with focused regulatory strategy insights, derived from deep knowledge and understanding of regulatory external/competitive environment.
• Ability to carry out highly tailored, expert precedent research, using a multitude of data sources and tools, to inform regulatory strategies.
• Develop cross-functional communication and implementation plans to convey complex regulatory policy issues with impact to the business.
• Ensure external analysis is internalized to facilitate product strategy and track progress.
• Due to the complexity and sensitivity of these needs, the incumbent must be able to demonstrate highly evolved strategic and influencing skills in interacting at all levels including senior leadership.
• Ability to work effectively and independently as an individual contributor in a highly collaborative and team-oriented environment are essential components in this role.

Knowledge and Skills:

• Ability to work in an intense, fast-paced, innovative work environment.
• Ability to work effectively as part of a global organization with internal executives and subject matter experts.
• Ability to lead cross-functional teams and drive to common goal.
• High degree of individual initiative/drive.
• Vendor and agency management experience.
• Strong verbal/written skills.

Education and Experience:

• Bachelor's degree in a scientific discipline such as pharmacy or a biological science, a law degree, or equivalent experience; higher degree preferred.
• Typically requires 10 years of experience including experience in drug development, regulatory affairs, policy and/or advocacy, or the equivalent combination of education and experience
• Recognized expertise in regulations, guidelines and precedents related to pharmaceutical development for innovative small molecules and biologics.
• In-depth understanding of biopharmaceutical R&D lifecycle, and broad, comprehensive knowledge of the functions with a biotechnology company and how they contribute to advancing product development and achieving corporate goals.
• Competitive intelligence and/or management consulting background would be advantageous.
• Skilled communicator and internal facilitator.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com