Current jobs related to Regulatory Affairs Specialist - Waltham, Massachusetts - BostonGene


  • Waltham, Massachusetts, United States Taylor Strategy Partners Full time

    Job Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and ensure compliance with regulatory requirements. The successful candidate will have a strong background in pharmaceutical industry experience, with a focus on regulatory affairs leadership roles.Key...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Regulatory Affairs DirectorDyne Therapeutics is seeking a highly skilled Regulatory Affairs Director to lead the planning, management, and execution of regulatory activities for our product candidates in Europe, UK, and Switzerland.This role requires a strong understanding of EU regulatory requirements and the ability to develop and implement effective...


  • Waltham, Massachusetts, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAt Dyne Therapeutics, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory strategy team, you will be responsible for driving forward our regulatory strategy and operational activities related to our muscle disease programs.The ideal candidate will have a strong...


  • Waltham, Massachusetts, United States Dragonfly Therapeutics, Inc. Full time

    Job DescriptionDragonfly Therapeutics, Inc. is seeking a highly skilled Regulatory & Medical Affairs professional to lead our Regulatory Affairs organization.The ideal candidate will have a strong background in regulatory strategy and a proven track record of implementing innovative approaches to achieve regulatory milestones and business objectives.Develop...


  • Waltham, Massachusetts, United States ROIVANT SCIENCES LTD Full time

    Job SummaryPulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. As a key member of the Pulmovant team, the Head of Regulatory Affairs and Quality will lead the global regulatory and quality strategy, providing filing expertise in all phases of development.Key...


  • Waltham, Massachusetts, United States BioSpace, Inc. Full time

    Regulatory Affairs Project ManagerAbout the Role:We are seeking an experienced Regulatory Affairs Project Manager to join our team at BioSpace, Inc. The successful candidate will work closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and...


  • Waltham, Massachusetts, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs Project ManagerThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team at BioSpace, Inc. This role is responsible for facilitating timely submission of high-quality data packages to US and international health authorities. The successful candidate will work closely with cross-functional teams...


  • Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job SummaryThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team, responsible for facilitating timely submission of high-quality data packages to US and international health authorities. This role provides support to cross-functional teams, tracks and coordinates deliverables for regulatory timelines, and develops...


  • Waltham, Massachusetts, United States Alkermes Full time

    Job SummaryAlkermes is seeking a highly skilled Associate Director to lead our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory strategies and guidance on post-approval CMC topics.Key ResponsibilitiesDevelop and lead regulatory CMC...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Job Title: Associate Director, Regulatory Affairs CMCCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to...


  • Waltham, Massachusetts, United States Alkermes Full time

    Job Description Overview: Alkermes is a global biopharmaceutical company dedicated to developing innovative treatments for complex and difficult-to-treat psychiatric and neurological disorders. We are seeking an experienced Associate Director of CMC Regulatory Affairs to join our team in Waltham, MA. Key Responsibilities:Develop and lead regulatory CMC...


  • Waltham, Massachusetts, United States Global Partners LP Full time

    We are seeking a skilled Government Affairs Specialist to join our team at Global Partners LP. This role will be responsible for implementing strategies to advance the company's legislative and political agenda. The ideal candidate will have a proven track record of building trusted relationships with key officials and policy staff.As a Government Affairs...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job DescriptionDeciphera Pharmaceuticals, a biopharmaceutical company, is seeking a highly skilled Regulatory CMC Senior Manager to join its growing Post-Approval Group within the Regulatory Affairs Organization. The primary responsibility of this position is to lead and execute post-approval CMC regulatory activities in support of Deciphera's globally...


  • Waltham, Massachusetts, United States Apellis Full time

    Job DescriptionApellis Pharmaceuticals is seeking an experienced Associate Director, Regulatory Advertising to lead the development and implementation of advertising and promotional strategies that comply with regulatory requirements worldwide. The successful candidate will have a deep understanding of US and global regulations and guidelines, as well as...


  • Waltham, Massachusetts, United States Syndax Pharmaceuticals Full time

    About the Role:Syndax Pharmaceuticals is seeking an Executive Director, Regulatory Operations to formulate and implement a regulatory operations vision and strategy for a commercial stage biotechnology company.The ideal candidate will be responsible for envisioning and implementing a fit-for-purpose Regulatory Information Management (RIM) system across...


  • Waltham, Massachusetts, United States CSL Behring Full time

    The role of Global Medical Affairs Operations Lead at CSL Behring is a senior position that requires a high degree of expertise in medical affairs operations. Reporting directly to the Executive Director, this individual will be responsible for overseeing the implementation of changes and innovations to support the transformation project in Medical...


  • Waltham, Massachusetts, United States AbbVie Full time

    Job DescriptionAbbVie's MissionAbbVie is committed to discovering and delivering innovative medicines and solutions that address serious health issues today and tomorrow.We strive to have a remarkable impact on people's lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...


  • Waltham, Massachusetts, United States Mythic Therapeutics Full time

    Job SummaryMythic Therapeutics is seeking a highly experienced Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations, Quality, Clinical Operations, and other functions...


  • Waltham, Massachusetts, United States New England Donor Services Full time

    Job DescriptionThe Community Projects Specialist plays a crucial role in developing and fostering strategic relationships with designated community groups to maximize the number of individuals registering as organ and tissue donors.Key responsibilities include instilling the pro-donation message among those individuals getting or renewing their drivers'...


  • Waltham, Massachusetts, United States GForce Life Sciences Full time

    Quality Systems SpecialistAt GForce Life Sciences, we are seeking a highly skilled Quality Systems Specialist to join our team. The successful candidate will be responsible for assisting in the governance of Quality System applications, including harmonization of processes across sites.Key Responsibilities: Assist in gathering requirements for improvements...

Regulatory Affairs Specialist

1 month ago


Waltham, Massachusetts, United States BostonGene Full time
Regulatory Manager Job Description

BostonGene is seeking a highly skilled Regulatory Manager to play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular techniques.

Key Responsibilities:

  • Develop and implement regulatory strategies and processes to ensure compliance with ISO standards and Good Laboratory Practice (GLP) requirements.
  • Provide strategic and tactical regulatory guidance to influence project planning and decision-making processes positively.
  • Develop clinical and commercial regulatory strategies for assigned products to facilitate successful study designs and timely registration with regulatory health authorities.
  • Collaborate with internal teams and diagnostic partners to align on co-development regulatory needs and expectations.
  • Prepare for and facilitate meetings with regulatory agencies in collaboration with diagnostic partners and internal teams.
  • Review and approve key diagnostic regulatory submissions to CDRH and global health authorities.
  • Interact with international regulatory colleagues and diagnostic partners to determine best practices and regulatory paths for development and global registration activities.
  • Assess the impact of relevant regulations on drug and diagnostic development and registration activities.

Qualifications:

  • PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering.
  • CLIA/CAP/NYS experience is required.
  • 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations.
  • 8 plus years of experience in medical device and/or IVD/CDx industry.
  • Proven experience in effectively communicating and working with US FDA, Competent Authorities, and other regulatory agencies.
  • Regulatory submissions experience.
  • Must be detail oriented, well-organized, and able to work both independently and in teams.
  • Exceptional written and strong verbal communication skills.

About BostonGene:

BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision-making in the fight against cancer. BostonGene's unique solution performs sophisticated analytics to aid clinicians in evaluating viable treatment options for each patient's individual genetics, tumor and tumor microenvironment, clinical characteristics, and disease profile. BostonGene's mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and the integration of scientific and clinical knowledge.