Director, Regulatory Strategy

Boston, MA, United States

Director, Regulatory Strategy page is loaded Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22162 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 [email protected].

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com  or follow us on Facebook , Twitter/X ,  LinkedIn ,  YouTube  and  Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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