Senior Director of Regulatory Affairs

4 weeks ago


Boston, Massachusetts, United States ProClinical Full time

Senior Director, Regulatory Affairs

**Job Summary:**

Proclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This position is pivotal in driving regulatory efforts for vaccine development programs.

**Primary Responsibilities:**

* Manage the full lifecycle of global regulatory submissions and approvals, ensuring compliance across major markets
* Develop and execute regulatory strategies for vaccine development programs
* Manage relationships with global health authorities
* Ensure product compliance across major markets
* Guide regulatory teams and manage submissions
* Mitigate risks while ensuring alignment with organizational priorities

**Requirements:**

* Strong background in regulatory strategy, particularly in the field of infectious diseases and vaccines
* Proven experience in leading regulatory meetings and securing approvals
* Ability to manage complex regulatory portfolios
* Strong leadership skills and strategic thinking

**About Proclinical:**

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. We are an equal opportunity employer.



  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job Title: Associate Director, Global Regulatory AffairsAt Takeda Pharmaceutical, we are seeking an experienced Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA.Job Summary:We are looking for a highly skilled and motivated individual to lead our global regulatory strategy and ensure compliance with regulatory requirements. The...


  • Boston, Massachusetts, United States Fairway Consulting Group Full time

    Job Summary:Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job SummaryThe Senior Director, Regulatory Strategy, is a key member of the Vertex Pharmaceuticals team responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs. This role plays a major role in shaping cohesive regulatory strategy across assigned programs and ensuring effective...


  • Boston, Massachusetts, United States Monte Rosa Therapeutics Full time

    Regulatory Affairs Senior Manager**Job Summary:**Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team. This role will focus on oncology, immunology, and related therapeutic areas.**Key Responsibilities:*** Develop and implement regulatory strategies to support the global development and approval of...


  • Boston, Massachusetts, United States Foundation Medicine Full time

    Job DescriptionThe Senior Specialist, Regulatory Affairs plays a pivotal role in supporting the regulatory submissions process by developing strategic plans and submitting materials to health authorities such as the FDA for approval of novel platforms.This position provides critical regulatory guidance to internal development teams and prepares comprehensive...


  • Boston, Massachusetts, United States Foundation Medicine Full time

    Job SummaryThe Senior Specialist, Regulatory Affairs will play a key role in supporting the regulatory submissions process through the development of regulatory strategy and submission of materials to health authorities such as the FDA for approval of novel platforms. This position will provide regulatory guidance to internal development teams and prepare...


  • Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistAt Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with global regulatory requirements.Responsibilities:Develop and implement...


  • Boston, Massachusetts, United States Foundation Medicine Full time

    About the RoleThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process by developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document...


  • Boston, Massachusetts, United States Vertex Full time

    Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...


  • Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for interpreting regulatory filings and leading cross-functional teams to ensure compliance with new or revised regulations.Key ResponsibilitiesInterpret regulatory filings and lead...


  • Boston, Massachusetts, United States Xenon Inc Full time

    About the RoleWe are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Xenon Inc. This role will be responsible for developing and implementing global regulatory strategies to support the advancement of our product pipeline.ResponsibilitiesProvide regulatory support on multidisciplinary project/clinical study teams, including...


  • Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

    Job SummaryAs a Regulatory Affairs Specialist at Katalyst Healthcares and Life Sciences, you will play a critical role in ensuring the compliance of our medical devices with global regulatory requirements. You will develop and implement global regulatory strategies for new and modified medical devices, providing regulatory guidance to cross-functional...


  • Boston, Massachusetts, United States Monte Rosa Therapeutics Full time

    Regulatory Affairs ProfessionalMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to support the global development and approval of our innovative therapies.This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing...


  • Boston, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job OverviewWhite Collar Technologies Inc. is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our life science consulting team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance to clients.Key Responsibilities:Develop and implement regulatory strategies to...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is seeking a highly skilled Associate Director to lead our Global Regulatory Affairs team. As a key member of our organization, you will be responsible for defining and developing global strategies to maximize regulatory success for complex and multiple projects.You will provide strategic and tactical advice to teams to...


  • Boston, Massachusetts, United States InsideHigherEd Full time

    Job Title: Senior Director, Student Affairs Finance and AdministrationThe Senior Director is a key member of the Division of Student Affairs/Dean of Students leadership team, providing business, financial, and analytical support to all units reporting to the Dean of Students. This includes triaging with Financial Assistance and other University colleagues to...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration...


  • Boston, Massachusetts, United States Empatica Full time

    Medical Affairs DirectorEmpatica is a pioneering digital healthcare company that has revolutionized the field of digital biomarker development and continuous patient monitoring driven by AI. Our platform consists of medical-grade smartwatches, software, and physiological and behavioral digital biomarkers, enabling the continuous remote monitoring of human...


  • Boston, Massachusetts, United States InsideHigherEd Full time

    Job SummaryThe Senior Director of Student Affairs Finance and Administration is a key member of the Division of Student Affairs leadership team. This role provides business, financial, and analytical support for all units reporting to the Dean of Students. The Senior Director oversees operations and administrative tasks, establishing and enforcing policies...


  • Boston, Massachusetts, United States PathAI Full time

    Regulatory Affairs Specialist RolePathAI is seeking an experienced Regulatory Affairs Specialist to support the development and approval of our diagnostic products. As a key member of our regulatory team, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and guidelines.Key Responsibilities:Prepare and manage...