Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Lead, IVD & Companion Diagnostics

Precede

Precede Biosciences in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our advanced diagnostics and companion programs, spanning FDA interactions to global submissions. This senior individual contributor role emphasizes hands-on drafting, cross-functional collaboration, and a proactive regulatory lead for biopharma collaborations, with responsibility from strategy through approval. #J-18808-Ljbffr Precede

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Lead, IVD & Companion Diagnostics in Cambridge, MA vacancy
  •  ...MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs. This senior role owns submissions from strategy...  ...interactions, coordinating US and global IVD submissions (510(k), De Novo, PMA),... 
    Senior
    Regulatory

    Precede Biosciences, Inc.

    Cambridge, MA
    3 days ago
  • $133.5k - $192.83k

    Job Title: Senior Quality Engineer, In Vitro DiagnosticsLocation...  ...Engineer - In Vitro Diagnostics is a senior subject...  ..., safety, and regulatory compliance of IVD’s across the full...  ...selection, and companion diagnostic programs,...  ...partners; lead laboratory qualification... 
    Senior
    Regulatory
    Full time
    Worldwide

    Sanofi

    Somerville, MA
    2 days ago
  •  ...attorney to join the North America Legal team as Senior Corporate Counsel for Patient Support Services & Diagnostic Testing. This role provides comprehensive legal...  ...collaborating with cross-functional partners across sales, regulatory, privacy, and compliance. A strong track record... 
    Senior
    Regulatory
    Contract work

    Sanofi

    Cambridge, MA
    4 days ago
  •  ...OverviewBicara Therapeutics is seeking a Senior Director, Brand Lead - US who will be responsible for...  ...• Partner with Medical Affairs, Regulatory, Legal/Compliance, Market Access, Commercial...  ...launching a therapeutic with a companion diagnostic (CDx)• Experience building brands... 
    Senior
    Regulatory
    Full time
    Temporary work
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    4 days ago
  • Nanopath Inc. seeks a Senior/Principal Scientist to lead verification and validation for its in vitro diagnostic platform. The role is hands-on, shaping requirements, protocols...  ...with Engineering, Quality, and Regulatory to support design control and regulatory submissions... 
    Senior
    Regulatory

    Nanopath Inc.

    Cambridge, MA
    1 day ago
  •  ...Complexity Testing CLIA LAB. You will oversee personnel, workflow, and quality control in a molecular diagnostics lab. The role requires leadership and compliance with regulatory standards, ensuring test accuracy and timely reporting. Ideal candidates will have relevant... 
    Regulatory

    Nanobiosym

    Cambridge, MA
    4 days ago
  • $178.5k - $257.83k

    Job Title: Senior Corporate Counsel, Patient Support Services and Diagnostic Testing Location: Morristown, NJAbout the JobWe are seeking an experienced attorney with...  ...and understand legislative, enforcement, and regulatory developments that may impact Sanofi's patient support... 
    Senior
    Regulatory
    Full time
    Contract work
    Work at office

    Sanofi

    Somerville, MA
    1 day ago
  • Chelsea Public Schools in Chelsea, MA is seeking a Lead - Evaluation Team Lead (CHS) to oversee IEP development, regulatory compliance, and program evaluation for students with disabilities. The role requires Massachusetts licensure in Special Education, at least 5 years... 
    Senior
    Regulatory

    Chelsea High School

    Chelsea, MA
    1 day ago
  •  ...drive EU MDR compliance initiatives for the Sleep & Respiratory Care team. You will lead cross-functional programs from planning through execution, balancing scope, budget, and regulatory requirements while engaging stakeholders and managing risks. The role emphasizes... 
    Senior
    Regulatory

    Philips

    Cambridge, MA
    4 days ago
  • Sanofi is seeking a Senior Manager of Regulatory Affairs Advertising and Promotion to independently review promotional materials and develop regulatory...  ...for campaigns. The role includes serving as regulatory lead for product launches and providing input on labeling and lifecycle... 
    Senior
    Regulatory

    Sanofi

    Cambridge, MA
    5 days ago
  • Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions... 
    Senior
    Regulatory

    Scholar-Rock

    Cambridge, MA
    3 days ago
  •  ...Associate Director of Small Molecule Analytical Development to lead analytical strategies and method development for small molecule...  ...appropriate controls, oversee impurity profiles, and contribute to regulatory submissions, collaborating with Process Chemistry, Formulation,... 
    Senior
    Regulatory

    Biogen

    Cambridge, MA
    1 day ago
  • Moderna seeks a Senior Manager, GRS Integration in Cambridge, MA to lead regulatory planning and execution for multiple programs. You will partner with GRLs, Country Regulatory Leads, and CMC teams to translate strategy into integrated plans, manage risks, and ensure timely... 
    Senior
    Regulatory

    Moderna

    Cambridge, MA
    5 days ago
  • Mass General Brigham is seeking an experienced Regulatory Affairs Coordinator for a nationwide Alzheimer's platform trial within the McCance...  ...Center. You will serve as the Center’s regulatory expert, leading regulatory risk management, planning, and regulatory... 
    Senior
    Regulatory

    1200 The General Hospital Corporation

    Somerville, MA
    1 day ago
  •  ...Property Supervisor to join the Supply Chain Leadership team in Reston, VA. The role focuses on government property management, regulatory compliance, and audit support, with on-site collaboration as needed in a hybrid setup. You will oversee GFP/IUID data, ensure records... 
    Senior
    Regulatory

    Draper

    Boston, MA
    1 day ago
  • $105k - $140k

    About the RoleThe Senior/Lead Analyst, Private Credit Operations role will be responsible for supporting all operational activities within...  ...compliance and trade execution processes.Stay abreast of regulatory requirements and understand investment guidelines across multiple... 
    Senior
    Regulatory
    Local area
    Remote work

    Loomis Sayles

    Boston, MA
    1 day ago
  • Brown University is seeking a Senior HRPP Administrator to oversee the administration and implementation of the Human Research Protection...  ...AAHRPP standards, with responsibilities including committee support, minutes, and regulatory advising. #J-18808-Ljbffr Brown University
    Senior
    Regulatory
    Remote job
    Local area

    Brown University

    Boston, MA
    2 days ago
  • AstraZeneca in Cambridge, MA is seeking a technical lead to advance AI for clinical development in oncology. You will shape strategy...  ...AI projects, and collaborate with teams across biometrics, regulatory, and study design to integrate novel AI into clinical trials. You... 
    Senior
    Regulatory

    AstraZeneca

    Cambridge, MA
    1 day ago
  • Sanofi is seeking a Senior Demand Lead in Cambridge, MA or Morristown, NJ to own market-level IBP processes and align stakeholders on a single...  .... You will partner with Demand Planners, BU finance, regulatory, and quality teams to ensure accurate demand forecasts, inventory... 
    Senior
    Regulatory

    BioSpace

    Cambridge, MA
    3 days ago
  • $119.7k - $222.3k

     ...motivated PK Sciences representative to lead the development and use of artificial intelligence...  ...the organization and interactions with regulatory agencies, as appropriateProactively...  ...years of experience to be considered for Senior Principal Scientist.Extensive and in-depth... 
    Senior
    Regulatory
    Full time

    Novartis

    Somerville, MA
    4 days ago
  • $145 - $170 per hour

     ...Search Open Jobs View our latest job openings and see how Eastridge can help you find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... Eastridge Workforce Solutions is committed to connecting skilled professionals with... 
    Senior
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Local area
    Remote work
    Monday to Friday
    Shift work

    Eastridge

    Boston, MA
    3 days ago
  • PROMETRIKA is a full-service CRO seeking a Senior Clinical Research Associate to oversee site monitoring, ensure GCP compliance, and...  ...sites in the United States. The role emphasizes data integrity, regulatory adherence, and collaboration with trial managers. Ideal candidates... 
    Senior
    Regulatory

    Prometrika LLC

    Cambridge, MA
    1 day ago
  •  ...Supply Chain in the Cambridge, MA area. This senior leadership role drives planning, readiness,...  ..., supply chain, manufacturing, quality, and regulatory teams. You will develop launch strategies, identify risks early, and lead cross-functional decision-making to accelerate... 
    Senior
    Regulatory

    DSJ Global

    Cambridge, MA
    3 days ago
  •  ...Massachusetts seeks an experienced Associate Director of Supply Chain and Logistics to lead end-to-end planning, procurement, and distribution of radiopharmaceuticals, with a focus on safety and regulatory compliance. You will optimize the supply chain, oversee logistics for... 
    Senior
    Regulatory

    Mariana Oncology, Inc.

    Watertown, MA
    4 days ago
  •  ...forefront of medical innovation? As the Senior Global Medical Affairs Leader for MASH, you...  ...& Development investment decisions, lead pre-launch scientific efforts, and accelerate...  ...understanding of healthcare system pathways, regulatory landscapes, market access, and... 
    Senior
    Regulatory
    Full time
    Worldwide
    Relocation package

    AstraZeneca

    Boston, MA
    1 day ago
  • Biogen is seeking a Senior Scientist to advance parenteral drug product development, leading sterile formulation efforts and technology transfer. You will work across...  ..., drive process validation, and contribute to regulatory submissions in a fast-paced, matrix... 
    Senior
    Regulatory

    Biogen, Inc.

    Cambridge, MA
    5 days ago
  • Relay Therapeutics is seeking a senior Drug Product Lead to drive formulation development and manufacturing process optimization across our pipeline...  ...goals. You will draft and review GMP documents, support regulatory submissions (IND/NDA) and guide technology transfer to... 
    Senior
    Regulatory

    Relay Therapeutics

    Cambridge, MA
    1 day ago
  • $110k - $160.91k

     ...infrastructure is essential. This role is focused on leading and overseeing routing and siting...  ...evaluation, stakeholder engagement, and regulatory documentation and state siting authority...  ..., Electric Transmission Line Siting Senior Lead, you will serve as a technical and... 
    Senior
    Regulatory
    Full time
    Fixed term contract
    Casual work
    Work at office
    Remote work
    Flexible hours
    Shift work

    ERM Group

    Boston, MA
    2 days ago
  • $174.75k - $252.42k

    Job Title: Senior Demand LeadLocation: Cambridge, MA or Morristown, NJHybrid Work Schedule...  ..., faster.Job PurposeThe Senior Demand Lead is the focal point of franchise management...  ...in the market such as product launches, regulatory, and commercial topics. The Senior Demand... 
    Senior
    Regulatory
    Full time
    Temporary work

    Sanofi

    Cambridge, MA
    2 days ago
  • Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying deep regulatory expertise to design, conduct, and report toxicology studies in rodents and non-rodents. The role emphasizes primary authorship... 
    Senior
    Regulatory

    BioSpace

    Cambridge, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Lead, IVD & Companion Diagnostics. Be the first to apply!