Regulatory Affairs Manager

6 days ago

Boston, United States Albion Rye Associates Full time

About Us

My client is an emerging clinical-stage biotechnology company with a robust pipeline of innovative therapies designed to address significant unmet medical needs. The team is driven by a passion for science, a commitment to excellence, and a culture that values collaboration and innovation. As we expand our development programs, they are seeking a Regulatory Affairs Manager to join our dynamic team.


Position Summary

The Regulatory Affairs Manager will be a key contributor in navigating the complex regulatory landscape, ensuring compliance, and facilitating the timely development and approval of our pipeline products. This role requires hands-on involvement in regulatory strategies and submissions, working closely with cross-functional teams to drive global regulatory activities for clinical and pre-commercial products.


Key Responsibilities

  • Develop and implement regulatory strategies to support clinical development and product registration objectives.
  • Ensure alignment with corporate goals, regulatory requirements, and emerging regulatory trends.
  • Lead the preparation, review, and submission of regulatory dossiers, including INDs/CTAs, amendments, annual reports, and responses to health authority inquiries.
  • Manage global regulatory submissions, ensuring compliance with FDA, EMA, and other regulatory agencies’ guidelines.
  • Serve as a point of contact for regulatory agencies, coordinating and leading meetings, responses, and communications.
  • Prepare teams for agency meetings and lead the development of briefing packages and related materials.
  • Partner with clinical, preclinical, quality, and CMC teams to ensure regulatory requirements are integrated into development plans.
  • Provide regulatory guidance throughout the lifecycle of the products in the pipeline.
  • Monitor and interpret regulatory trends and guidance documents, advising teams on potential impact to development programs.
  • Maintain an up-to-date understanding of global regulatory requirements.


Qualifications

  • Bachelor’s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., MS, PharmD, PhD) preferred.
  • Minimum of 5-7 years of regulatory affairs experience in the biotech or pharmaceutical industry.
  • Proven track record in preparing and managing regulatory submissions (INDs, CTAs, etc.) and interfacing with regulatory agencies.
  • Experience with products in clinical development stages is required.
  • Strong understanding of global regulatory requirements, including FDA, EMA, and ICH guidelines.
  • Excellent project management, organizational, and problem-solving skills.
  • Strong communication and interpersonal skills with a demonstrated ability to work effectively in a cross-functional team environment.

  • Regulatory Affairs Manager

    15 hours ago

    Boston, United States ArkeaBio Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceCompany: Arkea Bio Corp.Role: Regulatory Affairs SpecialistManager: Senior Lead, Clinical DevelopmentLocation: Preferably Hybrid (Boston/Remote)Travel: Less than 25%Type: Full-TimeJob Summary:The Regulatory Affairs Specialist will be responsible for the preparation, and review of regulatory...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Boston, United States Disability Solutions Full time

    About the Job The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process for FMI data products or platforms that leverage data from those products. The incumbent functions as the regulatory representative on cross-functional...

  • Global Regulatory Affairs Manager

    1 week ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleTakeda Pharmaceutical is looking for a skilled Global Regulatory Affairs Manager to lead our global regulatory strategy. The ideal candidate will have extensive experience in pharmaceutical regulatory affairs and a deep understanding of regulatory requirements.Job DescriptionThe Senior Director, Global Regulatory Lead, GI will develop and...

  • Senior Manager, Regulatory Affairs

    1 month ago

    Boston, United States Foundation Medicine Full time

    Job DescriptionAbout the Job The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process for FMI data products or platforms that leverage data from those products. The incumbent functions as the regulatory representative on...

  • Regulatory Affairs Expert

    3 weeks ago

    Boston, Massachusetts, United States ArkeaBio Full time

    Job SummaryThe Regulatory Affairs Specialist at ArkeaBio will be responsible for preparing and reviewing regulatory documents for a novel veterinary product across multiple international jurisdictions. This role requires a strong understanding of regulatory requirements, excellent organizational skills, and the ability to work independently while...

  • Vice President Regulatory Affairs

    1 month ago

    Boston, United States EPM Scientific Full time

    Title: Vice President Regulatory AffairsAn exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to...

  • Vice President Regulatory Affairs

    6 days ago

    Boston, United States EPM Scientific Full time

    Title: Vice President Regulatory AffairsAn exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to...

  • Vice President Regulatory Affairs

    1 month ago

    Boston, United States EPM Scientific Full time

    Job DescriptionJob DescriptionTitle: Vice President Regulatory AffairsAn exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the...

  • Regulatory Affairs Strategist

    1 week ago

    Boston, Massachusetts, United States Lifelancer Full time

    Job OverviewLifelancer is seeking a highly skilled Regulatory Affairs Strategist to join our team. As a key member of our regulatory affairs department, you will be responsible for contributing and delivering global regulatory strategies for product development and approval.About the RoleThis is a challenging opportunity for an experienced professional to...

  • Senior Manager, Regulatory Affairs

    3 months ago

    Boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    2 months ago

    boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Manager, Regulatory Affairs

    3 months ago

    Boston, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Director of Regulatory Affairs

    1 month ago

    Boston, United States Albion Rye Associates Full time

    About the CompanyA cutting-edge pre-clinical biotechnology company dedicated to developing innovative small-molecule therapies to address unmet medical needs. Our mission is to translate groundbreaking science into transformative therapies for patients worldwide.As we advance our pipeline, we are seeking a seasoned Director of Regulatory Affairs to lead and...

  • Vice President Regulatory Affairs

    15 hours ago

    Boston, United States Discover International Full time

    We're currently partnering with a dynamic and fast-growing biotech company that is seeking to add a VP of Regulatory Affairs to its leadership team. This is a unique and exciting opportunity as the company is making significant strides in developing an innovative portfolio. Their focus spans several high-impact therapeutic areas, primarily addressing...

  • Vice President Regulatory Affairs

    6 hours ago

    Boston, United States Discover International Full time

    We're currently partnering with a dynamic and fast-growing biotech company that is seeking to add a VP of Regulatory Affairs to its leadership team. This is a unique and exciting opportunity as the company is making significant strides in developing an innovative portfolio. Their focus spans several high-impact therapeutic areas, primarily addressing...

  • Albion Rye Associates | Regulatory Affairs Manager

    2 weeks ago

    boston, United States Albion Rye Associates Full time

    About UsMy client is an emerging clinical-stage biotechnology company with a robust pipeline of innovative therapies designed to address significant unmet medical needs. The team is driven by a passion for science, a commitment to excellence, and a culture that values collaboration and innovation. As we expand our development programs, they are seeking a...

  • Regulatory Affairs Lead

    1 week ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job OverviewTakeda Pharmaceutical is seeking a highly skilled Regulatory Affairs professional to join our team as Associate Director, Global Regulatory Affairs Marketed Products.About the RoleThis role will be responsible for defining and developing global regulatory strategies to maximize regulatory success for complex and multiple projects. The successful...

  • Senior Manager/Associate Director, Regulatory Affairs

    14 hours ago

    Boston, United States Lifelancer Full time

    Job DescriptionJob DescriptionJob Title: Senior Manager/Associate Director, Regulatory AffairsJob Location: Boston, MA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelTitle: Seeking a Senior Manager/Associate Director for Regulatory AffairsPosition Purpose: The Senior Manager/Associate Director of Regulatory...

  • Regulatory Affairs Professional

    1 week ago

    Boston, Massachusetts, United States Great Gray, LLC Full time

    Key ResponsibilitiesThe Regulatory Affairs Professional will be responsible for reviewing advertising and sales literature to ensure compliance with regulations and internal policies. This role will also involve working closely with our business colleagues to develop compliant solutions to business needs.The successful candidate will have experience in...

  • Global Regulatory Affairs Leader

    1 week ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Join Our TeamWe are a dynamic and innovative company, dedicated to delivering life-changing medicines to patients worldwide. As a Global Regulatory Affairs Leader, you will play a critical role in shaping the future of our regulatory strategy, driving business growth, and improving operational efficiency.About the RoleThis is an exceptional opportunity to...