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Director, Regulatory Strategy

Semma Therapeutics

Semma Therapeutics

Legal
Boston, MA, USA
Posted on Monday, June 3, 2024

Job Description

The Regulatory Strategy Director 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 roles 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 collaborate 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 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 area of expertise

  • Provides regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity

Knowledge and Skills:

  • Experienced in Regulatory Affairs strategy in assigned geographic region, including direct interactions with a variety of stakeholders

  • Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use.

  • Proficient 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.

  • 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.

  • 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 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, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-Hybrid #LI-AR1

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.