Director, Regulatory Strategy

5 days ago

Boston, United States Vertex Pharmaceuticals Incorporated Full time

Job Description

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 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.
  • Addressees 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; or select

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

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.

#J-18808-Ljbffr

  • Senior Director, Regulatory Strategy

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Full time

    Senior Director, Regulatory StrategyJob DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies...

  • Senior Director, Regulatory Strategy

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in...

  • Director of Global Regulatory Strategy and Development

    1 day ago

    Boston, Massachusetts, United States Planet Pharma Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Global Regulatory Strategy and Development to join our team at Planet Pharma. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing global and US regulatory strategies for our unique and technologically complex products serving...

  • Senior Manager/Associate Director, Regulatory Strategy

    2 months ago

    Boston, United States Inozyme Pharma Full time

    Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are...

  • Director, Global Regulatory Affairs, Development Strategy

    5 days ago

    Boston, United States AstraZeneca GmbH Full time

    Director, Global Regulatory Affairs, Development StrategyThis is what you will do:Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.You will be responsible for:Developing and...

  • Associate Director, Regulatory Affairs

    1 month ago

    Boston, United States Monte Rosa Therapeutics Full time

    Associate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...

  • Associate Director, Regulatory Affairs

    1 month ago

    Boston, United States Monte Rosa Therapeutics Full time

    Associate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...

  • Associate Director, Regulatory Affairs

    1 week ago

    boston, United States Monte Rosa Therapeutics Full time

    Associate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...

  • Senior Manager/Associate Director of Regulatory Strategy

    1 month ago

    Boston, United States Inozyme Pharma Full time

    Position Overview: As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with...

  • Senior Manager/Associate Director, Regulatory Strategy

    2 months ago

    Boston, Massachusetts, United States Inozyme Pharma Full time

    Company Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing...

  • Senior Manager/Associate Director of Regulatory Strategy

    1 month ago

    Boston, Massachusetts, United States Inozyme Pharma Full time

    Position Overview:As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory...

  • Director of Regulatory Affairs

    2 weeks ago

    Boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...

  • Director of Regulatory Affairs

    2 weeks ago

    Boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...

  • Director of Regulatory Affairs

    1 week ago

    boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...

  • Director of Regulatory Affairs

    1 week ago

    boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...

  • Director of Regulatory Affairs

    3 months ago

    Boston, United States JRG Partners Full time

    Job DescriptionJob DescriptionJob Title: Director of Regulatory AffairsJob Description:As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes, you will lead the...

  • Director, Regulatory Labeling

    5 days ago

    Boston, United States Proclinical Staffing Full time

    Director, Regulatory Labeling - Permanent - BostonAre you a creative regulatory leader ready to shape the future of respiratory products? Proclinical is collaborating with a pioneering pharmaceutical company that is seeking a Director of Regulatory Labeling to spearhead the delivery of cutting-edge labeling for key products in the US and major global...

  • Director, Regulatory Labeling

    5 days ago

    Boston, United States Proclinical Staffing Full time

    Director, Regulatory Labeling - Permanent - BostonAre you a creative regulatory leader ready to shape the future of respiratory products? Proclinical is collaborating with a pioneering pharmaceutical company that is seeking a Director of Regulatory Labeling to spearhead the delivery of cutting-edge labeling for key products in the US and major global...

  • Regulatory Affairs Director

    5 days ago

    Boston, Massachusetts, United States Fairway Consulting Group Full time

    Job Description:Job Title: Regulatory Affairs DirectorCompany: Fairway Consulting GroupJob Type: Full-timeLocation: RemoteJob Category: Healthcare, Life SciencesAbout Us: Fairway Consulting Group is a leading executive search firm specializing in healthcare and life sciences recruitment.Job Summary: We are seeking an experienced Regulatory Affairs Director...

  • Director, Regulatory Labeling

    6 days ago

    Boston, United States Proclinical Staffing Full time

    Director, Regulatory Labeling - Permanent - BostonAre you a creative regulatory leader ready to shape the future of respiratory products? Proclinical is collaborating with a pioneering pharmaceutical company that is seeking a Director of Regulatory Labeling to spearhead the delivery of cutting-edge labeling for key products in the US and major global...