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

Senior Global Regulatory Affairs: CMC/Devices Lead

Katalyst CRO

Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory affairs, candidates should have 6+ years of relevant experience and a BS/BA in a scientific discipline. Strong analytical and communication skills are essential for this role. #J-18808-Ljbffr

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Global Regulatory Affairs: CMC/Devices Lead in Boston, MA vacancy
  • $212k - $333.19k

     ...therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you...  ...driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and... 
    Senior
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    JobRx, Inc.

    Boston, MA
    4 days ago
  •  ...Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies for device and drug-device combinations. This position...  ...strategies, interfacing with global health authorities, and ensuring... 
    Suggested

    Takeda

    Boston, MA
    2 days ago
  • $238k - $374k

     ...Initial Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have... 
    Suggested

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  •  ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating... 
    Senior

    Medella Life

    Cambridge, MA
    3 days ago
  • $148.5k - $214.5k

     ...Job title CMC dossier leader Location : Framingham,...  ...department within Sanofi R&D Global CMC Development...  ...and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement...  ...and/or regulatory affairs. AI applications and prompt... 
    Suggested

    Mass Digital Health

    Cambridge, MA
    4 days ago
  • $130.8k - $209.4k

     ...Initial Therapeutics, Inc. is seeking a Financial Planning and Analysis Lead in Cambridge, MA. This role involves leading financial planning and analysis for the CMC function, partnering closely to manage corporate forecasts and reporting. Candidates should have 5+ years... 
    Senior

    Initial Therapeutics, Inc.

    Cambridge, MA
    5 days ago
  • $215.67k - $237.5k

    Danaher Corporation is seeking a Senior Intellectual Property Counsel to provide legal advice on IP issues and manage patent applications. The role demands a Juris Doctorate with active bar membership and at least 7 years of experience in a law firm and as in-house counsel... 
    Senior
    Remote job

    Danaher Corporation

    Boston, MA
    1 day ago
  •  ...A leading technology firm in Boston seeks a Senior Industry Principal to advise C-suite stakeholders on supply chain transformation. This remote position requires 10-15 years of experience in consulting or industry leadership. The ideal candidate will possess deep expertise... 
    Senior
    Remote work

    Kinaxis

    Boston, MA
    4 days ago
  • $220k - $290k

     ...and are exploring regulatory pathways for...  ...CRO Regulatory lead supporting OUS development...  ...term plans. The Senior Director, Regulatory Affairs has foresight,...  ...and implement a global regulatory...  ..., biologics and devices) development, registration...  ...program. Guide CMC, nonclinical and... 
    Senior
    Temporary work
    For contractors
    Work at office
    Weekday work

    Verastem Oncology

    Boston, MA
    2 days ago
  • $75.05k

     ...Paid Social – Havas Media Network North America Full‑time. Salary: $75,050.00 per year. Responsibilities include leading paid social initiatives within the global Social Team. Licensed Clinical Social Worker (LCSW) – Full‑Time Full‑time. Role focuses on delivering clinical... 
    Senior
    Full time

    Prodigious Worldwide

    Boston, MA
    3 days ago
  • A health organization is seeking a Senior Credentialing Specialist to oversee provider credentialing and ensure compliance with health plan requirements. This role involves supervising credentialing staff, maintaining provider data in EMR systems, and managing licensing... 
    Senior
    Remote work

    Better Life Partners

    Boston, MA
    4 days ago
  •  ...Senior Manager – Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global Clinical Programs I’m currently supporting an innovative...  ...Strategy, Clinical, CMC, and external partners to...  ...as Regulatory Operations Lead for submission planning... 
    Senior

    Meet Life Sciences

    Boston, MA
    1 day ago
  • $146.3k - $234.1k

     ...You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance...  ...regulation and patient impact Close collaboration with senior leaders and cross‑functional experts across the... 
    Hourly pay
    Work experience placement
    Local area
    Remote work
    Worldwide

    Biontech

    Cambridge, MA
    21 days ago
  • $94k - $150k

     ...Senior Regulatory Affairs Specialist The Senior Regulatory Affairs Specialist for Ultrasound...  ...of Conformity, and Medical Device Licensesfor various global markets. Support cross-functional...  ...changes to existing products. Lead global regulatory intelligence initiatives... 
    Senior
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Cambridge, MA
    5 days ago
  • $154.4k - $242.55k

     ...Job Description The Global Brand Lead, ITP (Associate Director) is responsible for driving global commercial initiatives during pre-commercialization...  .... This role partners closely with Medical, Legal, and Regulatory teams to ensure materials are compliant, impactful, and... 
    Minimum wage
    Full time
    Temporary work
    Local area

    JobRx, Inc.

    Cambridge, MA
    4 days ago
  • $196.7k - $353.4k

     ...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development... 
    Senior
    Permanent employment
    Work at office
    Work from home

    Moderna

    Cambridge, MA
    2 days ago
  •  ...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy...  ...Responsibilities Develop and execute integrated global regulatory strategies to advance...  ...teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations... 
    Senior
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    2 days ago
  • $110k - $180k

     ...Barings LLC is seeking an Associate Director/Director Structuring Lead in Boston, MA. This role will lead the structuring, execution, and operational design of financing structures, collaborating cross-functionally with teams on transaction documentation. The ideal candidate... 
    Senior

    Barings

    Boston, MA
    4 days ago
  • $196k - $294k

     ...make Klaviyo special. About the Role Klaviyo is seeking a Senior Lead Product Manager to drive our Enterprise product strategy and...  ..., retention, and ARR growth. Represent the voice of large, global customers in strategic product discussions. B2C CRM for Enterprise... 
    Senior
    Worldwide

    Klaviyo

    Boston, MA
    1 day ago
  •  ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission... 
    Senior
    Full time
    Remote work

    Barrington James

    Boston, MA
    4 days ago
  •  ...,  X and  YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to...  ...Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand... 
    Senior
    Full time
    Work at office
    Local area
    Remote work

    AbbVie

    Waltham, MA
    1 day ago
  • $196k - $269.5k

     ...To help realize our ambitions, the argenx Global Commercial Team is looking for a Director, Global Indication Lead, Rheumatology. In this key role, you will be...  ...preferred Deep understanding of the legal, regulatory and commercial environment across major global... 
    Temporary work
    Work at office
    Remote work

    Argenx

    Boston, MA
    2 days ago
  • $245.45k - $381.11k

     ...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible...  ...across the company’s portfolio. This senior leader will provide strategic vision...  ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate... 
    Temporary work
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Boston, MA
    2 days ago
  •  ...Founded in 1977, GMO is a global investment manager committed...  ...investment bubbles and also as a leading climate investor and advocate...  ...Overview:   GMO seeks to add a senior attorney to its Legal Team....  ...relationships, and regulatory requirements, with a particular... 
    Senior
    Local area
    Worldwide
    Flexible hours

    GMO

    Boston, MA
    8 days ago
  •  ...A federal contracting agency is seeking a Senior Billing Specialist in Boston, Massachusetts. The role involves managing the e-billing process and supervising staff, ensuring accuracy in payments and billing reports. Candidates should have at least five years of legal... 
    Senior

    CGS Federal (Contact Government Services)

    Boston, MA
    4 days ago
  •  ...Join to apply for the Senior Regulatory Affairs Manager role at Katalyst CRO . Location: Cambridge, MA Responsibilities Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan... 
    Senior
    Contract work

    Katalyst CRO

    Boston, MA
    5 days ago
  • $180k - $245k

     ...Aon is seeking a Senior Property Placement Broker specializing in Power and Renewable Energy in Boston, MA. This role involves developing strategic solutions for clients, marketing property insurance programs, and managing client relationships. The ideal candidate will... 
    Senior

    Aon

    Boston, MA
    4 days ago
  •  ...Group is looking for a skilled Medical Device Development Engineer in Cambridge, Massachusetts...  ...on mechanical design, testing, and regulatory compliance. Ideal candidates will have...  ...ability to work in a dynamic environment while leading project teams. #J-18808-Ljbffr... 
    Senior

    Planet Pharma Group

    Cambridge, MA
    4 days ago
  •  ...A leading technology research firm in Boston is seeking a Database Team Lead to oversee the design and administration of enterprise database platforms. You will lead a team ensuring performance, availability, and security in a federal IT environment. Candidates must have... 
    Senior

    ASM Research, An Accenture Federal Services Company

    Boston, MA
    3 days ago
  • A nonprofit organization is seeking a Senior Finance Officer to oversee finance operations across various entities, ensuring robust financial management and compliance. The ideal candidate will have over 7 years of nonprofit finance experience, expertise in Sage Intacct... 
    Senior
    Remote work

    Movement Voter Project

    Boston, MA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Global Regulatory Affairs: CMC/Devices Lead. Be the first to apply!