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

Global CMC Regulatory Lead

Initial Therapeutics, Inc.

Initial Therapeutics, Inc. is looking for a GRA CMC Manager in King of Prussia, Pennsylvania. The successful candidate will lead key strategic and operational CMC regulatory activities across product development and lifecycle management. This includes driving regulatory strategies for clinical trial applications, assessing changes, and being the primary liaison with technical experts. Applicants should have a degree in natural sciences, a minimum of 5 years' experience in the biotech industry, and solid regulatory knowledge. Exceptional communication and problem-solving skills are essential. #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Lead in King of Prussia, PA vacancy
  •  ...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 markets. The... 
    Regulatory

    Johnson & Johnson Innovative Medicine

    Spring House, PA
    2 days ago
  • CSL Plasma Inc. is seeking a Head of Global Regulatory Affairs CMC to oversee regulatory strategy and operations. This role is critical in developing...  ...background in biological sciences, and the ability to lead cross-functional teams effectively to achieve compliance and... 
    Regulatory

    CSL Plasma Inc.

    King of Prussia, PA
    13 hours ago
  • IQVIA in Wayne, PA seeks an Associate Director of Global Regulatory Advertising and Promotion to ensure compliant promotional activities across...  ...knowledge of FDA OPDP/APLB guidance. The candidate will lead PMRT/MRC discussions, assist with regulatory submissions (225... 
    Regulatory

    IQVIA

    Wayne, PA
    4 days ago
  • $253k - $309k

     ...team is connected by our shared purpose: leading the fight against MASH.Madrigal’s...  ..., in the right way.The Senior Director, Global Publications Lead is responsible for leading...  ...development, commercial, compliance, legal, and regulatory affairs to ensure consistent... 
    Regulatory
    Full time
    Freelance
    Work at office
    Local area
    Flexible hours
    Night shift
    3 days per week

    Madrigal Pharmaceuticals

    Conshohocken, PA
    3 days ago
  • 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... 
    Regulatory

    BioSpace

    King of Prussia, PA
    3 days ago
  • TE Connectivity is seeking a globally oriented BU Manager in Global Trade Services to drive import/export compliance...  ...partners with GTS and BU stakeholders to ensure regulatory adherence and operational efficiency. You will lead trade compliance activities, oversee KPIs, and... 
    Regulatory

    TE Connectivity

    Wayne, PA
    1 day ago
  • $75k - $105k

     ...shop floor and laboratory systems in a globally distributed setting is highly desirable...  ...presentations preferred Experience building and leading high-performing, innovative, and...  ...in Project Management Knowledge of Regulatory Compliance Team Leadership & Development... 
    Regulatory
    Full time
    Worldwide

    CSL Behring

    King of Prussia, PA
    1 day ago
  • $171.75k - $286.25k

     ...role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff...  ...directly to the GRS TG Portfolio Lead. The Regulatory Director/Team Leader along...  ...Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions. Experience assessing... 
    Regulatory
    Local area

    GlaxoSmithKline

    Mont Clare, PA
    1 day ago
  • $117k - $201.25k

     ...Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/...  ...talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC.Purpose: The Principal Scientist of Global...  .... The primary responsibility is to lead the CMC regulatory activities related... 
    Regulatory
    Full time
    Local area
    Immediate start

    Johnson & Johnson

    Spring House, PA
    2 days ago
  • $129k - $153k

     ...worldwide.Position Overview: Regulatory leaders who leverage regional...  ...innovative, scientifically sound, global, integrated regulatory vision/...  ...other regional, labeling and CMC GRAST members to ensure ‘One...  ...regulatory deliverables (including leading assigned tasks) while... 
    Regulatory
    Full time
    Worldwide
    Relocation package

    CSL

    King of Prussia, PA
    8 hours ago
  •  ...driving strategic financial decisions across a global organization. This position offers the...  ...'ll Do Financial Analysis & Forecasting Lead complex financial modeling, forecasting,...  ...advisor across accounting, finance, and regulatory functions. Develop and present executive‑... 
    Regulatory

    Liberty Personnel Services, Inc.

    King of Prussia, PA
    3 days ago
  • Teleflex, a global medical technologies company headquartered near Philadelphia in Wayne,...  ...and coordinate with stakeholders to ensure regulatory compliance across functions. You will...  ...partner with CSR and cross-functional teams, lead risk assessments, and drive program... 
    Regulatory
    Work at office

    Teleflex

    Wayne, PA
    1 day ago
  • West Pharmaceutical Services is seeking a Principal, Regulatory Affairs - Intelligence, Pharmaceutical to lead regulatory intelligence strategies. The role emphasizes containment systems, primary packaging, and global regulatory frameworks across product lifecycle.... 
    Regulatory

    West Pharmaceutical Services

    Exton, PA
    1 day ago
  • A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality... 
    Regulatory
    For contractors
    Remote work

    Joulé

    Collegeville, PA
    1 day ago
  • Position PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global...  ...innovative, timely regulatory CMC solutions that meet evolving regulatory...  ...timely delivery.Demonstrated ability to lead cross-functional teams and... 
    Regulatory
    Full time
    Flexible hours

    CSL

    King of Prussia, PA
    2 days ago
  • IQVIA is seeking an experienced Site Activation Lead to drive the strategic, operational, and financial delivery of site activation activities. You will manage Site ID, Ethics, Regulatory, and Site Contracting for assigned studies across regions, ensuring fast patient enrollment... 
    Regulatory

    IQVIA

    Wayne, PA
    1 day ago
  • Blue Cross Blue Shield Global SolutionsSM (BCBS Global SolutionsSM) seeks a Manager, Claims Systems to lead the team responsible for claims administration systems, ensuring...  ...ownership of product enablement, regulatory alignment, and risk-driven improvements to... 
    Regulatory

    Socket

    King of Prussia, PA
    13 hours ago
  • Ecolab is seeking a Biopharma Regulatory Strategist to shape and execute regulatory strategies that accelerate growth across Life Sciences...  ...across the full biopharma lifecycle. You will bring deep CMC expertise, and strong business acumen to translate regulatory change... 
    Regulatory

    ECOLAB

    King of Prussia, PA
    1 day ago
  •  ...United States is seeking a Senior Leader for Global Clinical Trial Operations (GCTO) Program...  ..., high-quality study execution. You will lead cross-functional teams across clinical...  ...optimize performance, risk management, and regulatory readiness in a complex global portfolio.... 
    Regulatory

    Merck

    North Wales, PA
    1 day ago
  •  ...Team Lead, Global Regulatory Affairs x 2 The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for: Partnering closely with CSL's R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy... 
    Regulatory
    Local area
    Flexible hours

    CSL

    King of Prussia, PA
    1 day ago
  •  ...Inc. seeks a seasoned TMF professional to lead governance and oversight of Trial Master...  ...will drive process improvements, ensure regulatory compliance, and coordinate with cross‑functional...  ...reporting. Strong communication and global regulatory experience are essential for... 
    Regulatory

    CSL Plasma Inc.

    King of Prussia, PA
    3 days ago
  • dsm-firmenich is seeking a Senior Director, Global Quality & Regulatory in Exton, PA. This leadership role entails ensuring compliance with regulatory requirements and maintaining product integrity while fostering a culture of continuous improvement. You will oversee global... 
    Regulatory

    dsm-firmenich

    Exton, PA
    3 days ago
  • West Pharmaceutical Services in Exton, PA, is seeking a Regulatory Materials Compliance professional to coord, author, and manage regulatory and environmental compliance for parenteral packaging, device, and contract manufacturing portfolios. The role focuses on timely... 
    Regulatory
    Contract work

    RXinsider LTD.

    Exton, PA
    2 days ago
  • The Opportunity:As the Lead Counsel Enterprise Contracting Americas (US, Canada, LATAM)...  ...Canada and LATAM, in particular support the global leadership teams located in King of...  ...contractual risks, ensuring compliance with regulatory requirements and organizational policies.... 
    Regulatory
    Full time
    Contract work
    Work at office
    Flexible hours

    CSL

    King of Prussia, PA
    1 day ago
  • Two Directors of Search & Evaluation to lead strategic sourcing and evaluation of external...  ..., coordinating scientific, clinical, regulatory, and commercial assessments to inform governance...  ....​About CSL BehringCSL Behring is a global biotherapeutics leader driven by our... 
    Regulatory
    Full time
    Work at office
    Work from home

    CSL

    King of Prussia, PA
    1 day ago
  • $263k - $328k

     ...Senior Director Search & Evaluation Late TA Lead, Immunology? The job is in our Waltham MA...  ...-stage assets, coordinating clinical, regulatory, commercial, and market access assessments...  ...-HYBRIDAbout CSL BehringCSL Behring is a global biotherapeutics leader driven by our... 
    Regulatory
    Full time
    Work at office
    Worldwide
    3 days per week

    CSL

    King of Prussia, PA
    2 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 LLP

    Collegeville, PA
    3 days ago
  •  ...Labeling Manager in Collegeville, PA. This role involves preparing local product documents and acting as a Subject Matter Expert on regulatory labeling requirements. The ideal candidate will have at least 1 year of pharmaceutical experience and possess strong analytical... 
    Regulatory
    Local area

    Real Staffing

    Collegeville, PA
    3 days ago
  •  ...seeking a Senior Director, Clinical Data Management Therapeutic Area Lead (Hematology) to provide strategic and operational leadership...  ...efficiency, standardization, and digital enablement across programs, ensuring regulatory compliance while #J-18808-Ljbffr Merck & Co.
    Regulatory

    Merck & Co.

    North Wales, PA
    13 hours ago
  • $144k - $176k

     ...team is connected by our shared purpose: leading the fight against MASH.Madrigal’s...  ...clinical trial data in accordance with regulatory standards and Madrigal Pharmaceuticals’...  ...leading data management for Phase II or III global studies.• Familiarity with adaptive trial... 
    Regulatory
    Minimum wage
    Full time
    Work at office
    Local area
    Flexible hours

    Madrigal Pharmaceuticals

    Conshohocken, PA
    13 hours ago

Do you want to receive more vacancies?

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