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

Global Regulatory CMC Strategist

BioSpace

CSL Behring in King of Prussia, PA, is seeking an experienced regulatory affairs professional to lead global regulatory CMC strategies and coordinate with R&D, Quality, and Global Operations to ensure timely submissions and compliant lifecycle management. The role emphasizes cross-functional collaboration, outsourcing management, regulatory intelligence, and continuous improvement to align regulatory activities with CSL’s strategic objectives and evolving global requirements. #J-18808-Ljbffr BioSpace

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Strategist in King of Prussia, PA vacancy
  • CSL Behring is seeking a Regulatory Affairs CMC leader to drive global regulatory strategies for biologics and plasma products. You will collaborate with Global Regulatory Affairs, R&D, Quality, and Global Operations to align regulatory plans with business objectives. The... 
    Regulatory

    Biopharma Careers

    King of Prussia, PA
    1 day ago
  • $163.1k

     ...CA, or Chicago, IL area Job Overview As a senior member of the Global Advisory Services team, you will work directly with Global HQ...  ...coherence. Stay ahead of industry, competitive, technology and regulatory trends to inform client discussions and shape differentiated value... 
    Regulatory
    Full time
    Part time
    Immediate start
    Worldwide

    IQVIA

    Wayne, PA
    1 day ago
  • Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, to drive global regulatory strategies for large molecules, vaccines, and delivery devices. You will lead CMC submissions and align with GRA leadership across... 
    Regulatory

    Johnson & Johnson Innovative Medicine

    Spring House, PA
    16 hours ago
  • Position PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address...  ...strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance... 
    Regulatory
    Full time
    Flexible hours

    CSL

    King of Prussia, PA
    5 days ago
  • CSL Behring seeks a Global Asset Integrity & Lifecycle Lead to develop and manage strategies for asset integrity and lifecycle management, ensuring compliance and cost-effectiveness across global operations. The role coordinates with regional teams, engineering, maintenance... 
    Suggested

    CSL Plasma Inc.

    King of Prussia, PA
    4 days ago
  •  ...King of Prussia, PA seeks a Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist to lead regulatory strategy across plasmapheresis devices, drug...  ...with R&D, Quality, Regulatory Affairs and Global Operations. You will serve as primary... 
    Regulatory

    BioSpace

    King of Prussia, PA
    2 days ago
  • CSL is seeking a Senior Manager, GRA CMC - Combination Product and Stand‑Alone Medical Device Specialist to lead global CMC regulatory strategy for drug‑device combination products and medical devices. In this role, you will design and execute CMC regulatory plans, author... 
    Regulatory
    Worldwide

    CSL

    Bridgeport, PA
    8 days ago
  • CSL is seeking an Associate Director GRA CMC SaMD & Cybersecurity Specialist to lead global CMC regulatory strategy for software as a medical device and digital components of our biotherapies and vaccines portfolio. You will ensure compliance with evolving global SaMD and... 
    Regulatory
    Worldwide

    CSL

    Bridgeport, PA
    8 days ago
  • Position: Principal eClinical Data Strategist Location: Lansdale, PAJob Id: 5668-01...  ...practices for clinical data handling to ensure compliance with global regulatory expectations.*This is a hybrid roleResponsibilities include... 
    Regulatory
    Temporary work
    Worldwide

    Almac

    Lansdale, PA
    3 days ago
  •  ...GVP Auditor in King of Prussia, PA, to ensure compliance with global audit plans and safety data accuracy. The successful candidate...  ...external partners and internal safety functions, requiring strong regulatory knowledge and quality assurance experience within a GVP-... 
    Regulatory

    CSL

    King of Prussia, PA
    1 day ago
  • $142.4k - $224.1k

    Job DescriptionAssociate Principal Scientist, Regulatory CMC Digital InnovationRahway, NJ or West Point, PAOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new... 
    Regulatory
    Full time
    For contractors
    Summer internship
    Local area

    Merck Sharp & Dohme (MSD)

    North Wales, PA
    2 days ago
  • $166.5k - $203.5k

     ...right time, in the right way.Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards and Training, this role...  ...coordination with cross-functional leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the QPPV Office) to gather... 
    Regulatory
    Minimum wage
    Full time
    Work at office
    Local area
    Flexible hours

    Madrigal Pharmaceuticals

    Conshohocken, PA
    4 days ago
  • $140k - $160k

     ...technically skilled and service-oriented Senior Financial Planning Strategist to join our High Net Worth Planning Services team. This role...  ...s strategic direction (e.g., industry trends, legislative and regulatory changes, etc.) Deliver presentations to internal and external... 
    Regulatory
    Full time
    For contractors
    Work at office
    Remote work

    Osaic

    Berwyn, PA
    2 days ago
  • $117k - $201.25k

     ...Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/...  ...is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products...  ...Chain team for post-approval programs), and Global Regulatory Team. This role will also support... 
    Regulatory
    Full time
    Local area
    Immediate start

    Johnson & Johnson

    Spring House, PA
    3 days ago
  •  ...is looking for an experienced, business-minded Senior Director, Global Product Counsel with commercial, data privacy, and compliance...  ...and end‑user/merchant agreements, data privacy and security, and regulatory considerations affecting hardware, software, SaaS, and cloud‑... 
    Regulatory
    Work at office
    Worldwide

    Verifone

    King of Prussia, PA
    3 days ago
  • Position Summary The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies for assigned...  ...teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions. Experience assessing and applying... 
    Regulatory
    Local area
    Remote work

    Biopharma Careers

    Mont Clare, PA
    1 day ago
  • $166.5k - $203.5k

     ...right time, in the right way. Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards and Training, this role...  ...with cross-functional leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the QPPV Office) to gather accurate... 
    Regulatory
    Minimum wage
    Full time
    Work at office
    Local area
    Flexible hours

    Madrigal Pharmaceuticals Corporation

    Conshohocken, PA
    a month ago
  •  ...Trial Disclosure and Transparency in King of Prussia, PA. This global role serves as the subject matter expert, guiding strategy, ensuring...  ...leading cross-functional engagement with Clinical Development, Regulatory, IP, Legal and Health Authorities, while ensuring #J-18808-... 
    Regulatory

    CSL Plasma

    King of Prussia, PA
    1 day ago
  •  ...Allied Universal® is hiring a Senior Manager - Internal Audit, Global SOX. The Senior Manager of Internal Audit - Global SOX will serve...  ...aspects of the SOX compliance program to ensure adherence to regulatory requirements and internal policies. RESPONSIBILITIES: Lead... 
    Regulatory
    Work at office
    Local area

    Allied Universal

    Conshohocken, PA
    9 days ago
  •  ...Director, Senior Counsel, Clinical to provide timely legal support to Global Clinical Development. The role is hybrid, with three onsite...  ...essential clinical agreements and advising on global regulatory issues. The successful candidate will have 8+ years of legal practice... 
    Regulatory

    CSL Plasma Inc.

    King of Prussia, PA
    3 days ago
  •  ...Director of Clinical Trial Disclosure and Transparency to lead global strategies and ensure timely, accurate, and compliant disclosures...  .... The candidate will collaborate with Clinical Development, Regulatory, Legal, and external vendors to embed transparency requirements... 
    Regulatory

    CSL Plasma Inc.

    King of Prussia, PA
    3 days ago
  •  ...Director of Clinical Trial Disclosure and Transparency to lead global strategies for compliant trial disclosures across all regions and...  ...partner with Clinical Development, Biostats, Medical Writing, Regulatory, Legal and Privacy teams to integrate disclosure requirements... 
    Regulatory

    Biopharma Careers

    King of Prussia, PA
    1 day ago
  • BCBS Global Solutions SM is seeking a Director of Clinical Services in King of Prussia, PA. The role leads medical review and care management...  ...departments, implement innovative care models, and ensure regulatory compliance while driving measurable value and cost management.... 
    Regulatory

    GeoBlue

    King of Prussia, PA
    4 days ago
  •  ...contingent labor as a variable cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product Leader for the...  ...packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling... 
    Regulatory
    Work at office
    Immediate start
    Flexible hours

    Artech

    Spring House, PA
    3 days ago
  • The Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist...  ...Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address...  ...collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs... 
    Regulatory
    Local area
    Worldwide
    Flexible hours

    BioSpace

    King of Prussia, PA
    2 days ago
  •  ...comprehensive audit reports, categorize risks, and drive CAPA actions in collaboration with global stakeholders. The role requires 3+ years in a GCP‑regulated QA environment, strong regulatory knowledge, and excellent communication. Up to 50% travel is possible to support... 
    Regulatory

    Biopharma Careers

    King of Prussia, PA
    2 days ago
  • West Pharmaceutical Services, Inc seeks a Senior Counsel, Compliance, Regulatory & Quality in Exton, PA. This strategic role offers integrated legal leadership across global Compliance, Regulatory Affairs and Quality Assurance functions. The incumbent will ensure compliance... 
    Regulatory

    West Pharmaceutical Services, Inc

    Exton, PA
    1 day ago
  • West Pharmaceutical Services, Inc. is seeking a Principal, Regulatory Affairs - Intelligence, Pharmaceutical in Exton, PA. This role requires deep expertise in global regulatory frameworks with a focus on containment systems and drug products, translating intelligence into... 
    Regulatory

    West Pharmaceutical Services, Inc

    Exton, PA
    1 day ago
  • CSL seeks a Global Automation Engineering & Technology Head to lead strategy and execution of automation across our biotechnology and...  ...vendor partnerships, and ensure cybersecurity, data integrity, and regulatory compliance while enabling innovation at scale across CSL’s... 
    Regulatory

    CSL

    Bridgeport, PA
    9 days ago
  • GSK is seeking an experienced HR Business Partner to provide partnering for Global Regulatory Affairs within the R&D HR team. You will lead and support change programs, coach senior leaders, and apply data-driven insights to drive organizational effectiveness. Role emphasizes... 
    Regulatory

    GSK

    Collegeville, PA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory CMC Strategist. Be the first to apply!