Director, Regulatory Strategy

Director, Regulatory Strategy

Job Description

General Summary:

The Director, Regulatory Strategy will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This role's assignments may be global, regional, or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational, and business knowledge into effective implementation plans and strategy.

Key Duties and Responsibilities:

• 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.
• Represents GRA on core development functional teams, project teams, and collaborates with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy.
• 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.
• Anticipates global regulatory changes and develops proactive strategy accordingly.
• Shapes the regulatory strategy for regulatory submission documents and Health Authority communications.
• Counsels and advises GRA leadership on the status of global Regulatory Affairs strategies and tactics, procedures, and practices.
• Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidance.
• Manages project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time.
• Contributes to the continuous improvement of existing department processes and strategies, providing recommendations in the area of expertise.
• Provides regulatory leadership to the GRA functional team(s) in context of participating in the skill development, coaching, and performance feedback for members of the GRA functional teams.
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedures, and guidance for pharmaceutical development of medicines for human use.
• Advanced knowledge of the research and development, preclinical, and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals.
• Proficiency in analyzing and interpreting data, protocols, safety reporting, labeling, and other activities related to the phases of drug development for assigned products.
• Proficient skills in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well-organized preparation of cross-functional teams.
• Advanced skill in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.
• Actively uses expertise to develop others by providing coaching, guidance, and mentoring.
• 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.
• Demonstrates excellent communication skills with the ability to impact and influence the decisions of a team.

Education and Experience:

• Bachelor's degree in Biology, Chemistry, or other related discipline.
• Typically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 3 years of supervisory/management experience, or the equivalent combination of education and experience.

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.