Director, Regulatory Strategy

25 Jul, 2022

Jobs

Director, Regulatory Strategy

Vertex Pharmaceuticals
Boston, MA

Job Description

General Summary:

 

Vertex Pharmaceuticals Inc. is looking to hire an Director to join the Global Regulatory Affairs (GRA) Strategy team in Boston, MA. The Associate Director Regulatory Strategy will be responsible for overseeing the development of global regulatory strategy for early and/or late-stage development product(s) within the Vertex Cystic Fibrosis portfolio. This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and ability to translate this into effective regulatory planning and strategy development.

 

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 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) 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, procedure 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 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 and 3 years of supervisory/management experience, 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 on regularly scheduled days; or select

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

 

#LI-EE1  #LI-Hybrid

 

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.

 

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.

Learn more here

Job posted: 2022-07-25