Current jobs related to Regulatory Affairs Director - Boston, Massachusetts - Fairway Consulting Group

  • 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...

  • Senior Director of Regulatory Affairs

    2 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,...

  • 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...

  • 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...

  • Regulatory Affairs Director

    6 days ago

    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...

  • 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 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

    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

    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 Director, Chemistry Manufacturing Controls

    2 weeks ago

    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...

  • 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

    2 weeks 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 Professional

    2 days ago

    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...

  • Regulatory Affairs Specialist

    2 weeks 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...

  • Global Regulatory Affairs Leader

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    5 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

    6 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...

  • Director, Regulatory Affairs CMC Small Molecules

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks 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 months ago

Boston, Massachusetts, United States Fairway Consulting Group Full time
Job Description:

Job Title: Regulatory Affairs Director

Company: Fairway Consulting Group

Job Type: Full-time

Location: Remote

Job Category: Healthcare, Life Sciences

About 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 to join our client's team. The successful candidate will be responsible for leading the development and implementation of regulatory strategies to ensure compliance with global regulations and guidelines.

Key Responsibilities:

  • Develop and implement regulatory strategies: Collaborate with cross-functional teams to develop and implement regulatory strategies that ensure compliance with global regulations and guidelines.
  • Ensure regulatory compliance: Ensure that all regulatory requirements are met, including those related to clinical trials, product development, and marketing.
  • Lead regulatory submissions: Lead the preparation and submission of regulatory documents, including INDs, NDAs, and MAAs.
  • Communicate with regulatory agencies: Develop and maintain relationships with regulatory agencies, including the FDA, EMA, and ICH.
  • Stay up-to-date with regulatory requirements: Stay current with changes in regulatory requirements and guidelines, and ensure that the company is in compliance.
  • Lead regulatory training: Develop and deliver regulatory training programs to ensure that all employees understand regulatory requirements.
  • Collaborate with cross-functional teams: Collaborate with cross-functional teams, including R&D, Quality, Clinical, and Manufacturing, to ensure that regulatory requirements are met throughout the product lifecycle.

Requirements:

  • Regulatory experience: Minimum 5 years of experience in regulatory affairs, with a strong understanding of global regulations and guidelines.
  • Leadership experience: Proven leadership experience, with the ability to lead cross-functional teams and develop and implement regulatory strategies.
  • Communication skills: Excellent communication and interpersonal skills, with the ability to communicate effectively with regulatory agencies, cross-functional teams, and senior leadership.
  • Regulatory knowledge: Comprehensive knowledge of global regulations and guidelines, including those related to clinical trials, product development, and marketing.
  • Project management skills: Strong project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.

What We Offer:

  • Competitive salary: A competitive salary and benefits package.
  • Opportunities for growth: Opportunities for growth and professional development.
  • Collaborative team: A collaborative and dynamic team environment.