Director, Regulatory Strategy, Pain

Job Description

General Summary:

The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for new product development within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting platform product portfolio strategy. This role will understand and translate regulatory, scientific, operational and business knowledge into actionable strategy and plans.

Key Duties and Responsibilities:

1. Leads the development of regulatory strategy for assigned projects/regions in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents supporting the Pain portfolio products development.
2. Represents GRA on core development functional teams and collaborates with regional regulatory leads to ensure unified regulatory input into clinical programs and commercial strategy.
3. Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership.
4. Assesses global regulatory requirements, risks and develops proactive mitigation strategies accordingly.
5. Shapes the regulatory strategy for regulatory submission documents and leads the communication with Health Authorities as needed.
6. Counsels and advises or seeks alignment with GRA leadership on status of global Regulatory Affairs strategies, critical factors, and tactics, procedures and recommendations.
7. Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidance.
8. Manages project plans with cross-functional teams to ensure all projects are appropriately prioritized and key goals are met on time.
9. Contributes to the continuous improvement of existing GRA department processes and strategies, providing recommendations in area of expertise.
10. Provides regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity, supervising junior regulatory associates and GRA fellows.

Knowledge and Skills:

1. Experienced in Regulatory Affairs strategy in product development and registration in US/North America, EU, including direct interactions with a variety of health authorities of interested regions.
2. Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks for NDA/BLA/IND/CTA. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of novel medicines for human use.
3. Proficient knowledge of the research and development, preclinical and clinical requirements for new drug development (e.g., pain, neurological drugs would be a plus, but not required). Particularly can understand the analyzing and interpreting data, protocols, safety reporting, labeling and other activities at various phases of drug development (phase 1 to phase 3) for assigned products.
4. Advanced skill in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development, and in leading productive health authority interactions, including well-organized preparation of cross-functional teams.
5. Actively uses expertise to develop others by providing coaching, guidance and mentoring.
6. A strong collaborative partner with cross-functional colleagues with the ability to build consensus through the ability to present a clear and compelling case for ideas.

Education and Experience:

1. Bachelor's degree in Biology, Chemistry, or other related discipline.
2. Typically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. 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