Current jobs related to Head of Regulatory Affairs and Compliance - Boston, Massachusetts - Charles River

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    3 weeks ago

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

    Regulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners and developing global regulatory strategies for new and modified medical devices.Key...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Director

    3 weeks ago

    Boston, Massachusetts, United States Spencer Rigby Full time

    Join Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...

  • Regulatory Affairs Director

    4 weeks ago

    Boston, Massachusetts, United States Spencer Rigby Full time

    Join Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...

  • Head of Regulatory Operations

    7 days ago

    Boston, Massachusetts, United States Takeda Full time

    Job DescriptionThe Head of Regulatory Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization. The role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...

  • Regulatory Affairs Director

    2 weeks ago

    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...

  • Head of Regulatory Operations

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionThe Head of Regulatory Operations at Takeda Pharmaceutical will be responsible for developing and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization.Key Responsibilities:Be a strategic thought partner to the Head of Regulatory about complex problems,...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    3 weeks ago

    Boston, Massachusetts, United States Foundation Medicine Full time

    About the JobThe 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 regulatory guidance to internal development teams and prepares document packages for...

  • Head of Global Regulatory Operations

    2 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionThe Head of Global Regulatory Operations will be responsible for developing and implementing the global regulatory affairs strategy to achieve a best-in-class regulatory operations organization.Key Responsibilities:Be a strategic thought partner to the Head of Regulatory Affairs on complex problems, current and future initiatives, strategies,...

  • Senior Director of Regulatory Affairs

    1 week 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,...

  • Regulatory Affairs Specialist

    2 days ago

    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...

  • Regulatory Affairs Specialist

    1 month ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Director

    2 weeks ago

    Boston, Massachusetts, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory AffairsMonte 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 our innovative...

  • Regulatory Affairs Specialist

    4 days ago

    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...

  • Global Regulatory Affairs Director

    3 weeks ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical Job OpportunityWe are seeking an experienced professional to join our team as an Associate Director, Global Regulatory Affairs. This role will be based in Cambridge, MA and will involve working on late-stage development projects in multiple indications, device platforms, and cell line changes.Key Responsibilities:Provide global...

  • Regulatory Affairs Specialist

    1 week ago

    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...

Head of Regulatory Affairs and Compliance

2 months ago

Boston, Massachusetts, United States Charles River Full time

Charles River is seeking a Head of Regulatory Affairs and Compliance to enhance our team across various locations in the United States. This pivotal role involves steering regulatory and compliance teams, managing client relations, and ensuring that our animal care programs adhere to all required standards.

Key Responsibilities:

  • Engage with regulatory bodies
  • Facilitate both internal and external audits
  • Deliver compliance reports to senior management
  • Craft the vision and strategic direction for regulatory services
  • Support financial planning and monitoring
  • Oversee the resolution of compliance-related incidents
  • Supervise regulatory consultants and IACUC members

Qualifications:

  • Must possess a veterinary degree
  • A minimum of 10 years of experience in a laboratory animal environment
  • Valid licensure to practice veterinary medicine
  • Diplomate status with ACLAM is required

The compensation for this role ranges from $210,000 to $250,000 annually, contingent upon experience and location.

Charles River operates as a contract research organization, providing a diverse array of services to assist clients in the drug development process. With a global footprint, we are committed to enhancing the quality of life through our scientific advancements.