Global Biopharma Regulatory Strategy Lead (CMC)
Dormont Manufacturing Co
Ecolab Life Sciences is seeking a Global Biopharma Regulatory Consultant to support its Bioprocessing division. This role involves ensuring companies navigate the complexities of regulatory filings, with responsibilities centering around collaboration with various internal teams and with global regulatory bodies. The ideal candidate will have at least 10 years of experience in CMC regulatory filing along with a Bachelor’s degree and a willingness to travel significantly. #J-18808-Ljbffr Dormont Manufacturing Co
$113.85k - $189.75k
We are a global biopharma company with bold ambitions to positively impact the health of 2.5 billion people... ...changing solutions. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects....RegulatoryLocal area- CSL Plasma Inc. is seeking a Head of Global Regulatory Affairs CMC to oversee regulatory strategy and operations. This role is critical in developing regulatory CMC... ...in biological sciences, and the ability to lead cross-functional teams effectively to achieve compliance...Regulatory
- ...doing the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the... ..., ensuring compliance with FDA expectations and global standards. Prepare and review technical...RegulatoryLocal area
- GSK is seeking a candidate to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for small molecule medicines. The role involves collaboration with R&D, supply, quality, and commercial teams to ensure compliance and support the growth of the team...RegulatoryRemote work
- GSK in Collegeville, PA is seeking a CMC Regulatory Affairs professional to lead regulatory strategy for mature vaccine projects. This role involves ensuring compliance with FDA regulations and collaborating with teams across development and lifecycle management. The ideal...Regulatory
- Initial Therapeutics, Inc. is seeking a Sr. Director, Head of Global Labeling Strategy to lead the Global Labeling strategy function. This leadership... ...managing a global team and ensuring compliance with regulatory standards while developing innovative labeling strategies...Regulatory
$153.9k - $230.8k
...technologies, is seeking a Global Biopharma Regulatory Consultant to support our rapidly... .... What You Will Do Global CMC Leadership: Serve as a... ...expert guidance on filing strategies for chromatography and other... ...steps. Proven ability to lead global regulatory strategies...RegulatoryHourly payMinimum wageLocal area- Women In Bio in Collegeville, Pennsylvania, is seeking an experienced CMC Regulatory Professional to lead regulatory strategy for product development and lifecycle. This role involves cross-functional collaboration to prepare regulatory submissions and ensure compliance...Regulatory
- ...Responsibilities Own end-to-end integrated HIV PrEP global brand/franchise strategy across priority audiences and... ...to the customer experience plan. Lead global campaign evolution and... ...relationships (e.g., Legal, Compliance, Regulatory, Promotions, Global Comms); thrives in...RegulatoryLocal area
- A leading global industrial technology firm is seeking an Infrastructure Platform Leader to oversee... ...involves defining global operations strategy, managing cloud and data center operations, and ensuring performance and regulatory compliance. Ideal candidates have over 1...Regulatory
- A global leader in the pharmaceutical sector is seeking a Senior Quality and Regulatory Manager to oversee quality systems and regulatory compliance across manufacturing locations... ...Quality Control. Responsibilities include leading teams, ensuring compliance with quality...Regulatory
- ...overseeing the full lifecycle of Microsoft 365 services, leading a team of engineers, and ensuring operational... ...experience, 5 years in leadership, and familiarity with regulatory environments. Join a globally recognized trading firm at the intersection of technology...Regulatory
- GlaxoSmithKline is seeking a regulatory professional to lead CMC strategies for small molecule medicines. This hybrid role involves collaborating with global teams while managing regulatory compliance and risk mitigation. The ideal candidate will have a strong background...Regulatory
- ...Description The Opportunity: The Sr. Director, Head of Global Labeling Strategy leads the Global Labeling strategy function within Global... ...engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development...RegulatoryLocal areaWorldwide
- Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work with cross‑functional... ...to expedite submission, review and approval of global CMC applications. Ensures all appropriate CMC...RegulatoryWork at officeLocal areaRemote workWorldwide
- ...South America or Europe. Associate Principal Scientist, Global Regulatory Lead reporting to the Executive Director, Fertility Lead... ...development and implementation of world-wide regulatory strategies, including CMC elements, for the medical devices and combination products...RegulatoryWork experience placementLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work
- ...processing in pharmacovigilance. This role focuses on ensuring compliance and optimizing processes in a global context, requiring significant expertise in regulatory practices. The ideal candidate will have at least 10 years in Clinical Trial and Post-marketing Pharmacovigilance...Regulatory
$230k - $270k
...living with cancer. As our new Senior Director, Global Strategy and Program Management , you'll play a key... ...Global Program Leader (GPL) and strategic lead for assigned tumor programs, bringing together development, regulatory, medical, commercial, and market access perspectives...RegulatoryWork at officeLocal areaFlexible hours3 days per week- GlaxoSmithKline is looking for a Regulatory Affairs Specialist in Upper Providence, Delaware, to lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for mature vaccine projects. You will ensure compliance with FDA regulations and drive innovation through...RegulatoryRemote work
$173.2k - $272.6k
...treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and... ...Principal Scientist, Global Labeling Lead is responsible for: developing, maintaining... ...assigned products in line with regulatory requirements and internal...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- Position overview Position Purpose The Head of Global Regulatory Affairs CMC - Network Strategy & Operation is responsible for partnering closely with global... ...compliance, and timely delivery. Demonstrated ability to lead cross-functional teams and collaborate effectively...RegulatoryFlexible hours
- MSD Malaysia is hiring an Associate Director for Global Marketing of MMRV. The role includes leading launch activities for the Varicella vaccine, managing franchise... ...coordinating with regional teams to drive global strategy. The ideal candidate will have at least 5 years of...
- ...regulation meet - translating CMC data into the submissions, change controls, and regulatory strategy that keep that supply moving without... ...with colleagues across Global Regulatory Affairs CMC, R&D, Quality... ...and innovative, leading therapies in iron deficiency and...Regulatory
$113.85k - $189.75k
...Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory activities for mature... ...filings. Coordinate global dossier assembly, review... ...biologics CMC regulatory strategy. Experience managing... ...Why GSK? GSK is a global biopharma company with a purpose...RegulatoryLocal area- ...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
- A data analytics leader is seeking a Senior Manager for the Global Incentive Strategy and Performance role in King of Prussia, PA. This position focuses on designing and optimizing performance-based incentive programs to enhance pipeline growth and revenue efficiency. The...
- Merck & Co. seeks an Associate Director for Global Marketing MMRV Strategy. You'll lead multiple workstreams to advance the MMRV franchise, significantly impacting public health. The ideal candidate will manage global strategies, collaborate with regional teams, and ensure...
- Novocure Inc is seeking a Senior Director for Global Strategy and Program Management to lead oncology programs focused on CNS and Lung Cancer. This leadership role involves strategic planning and execution to maximize the clinical and commercial value of cancer treatments...Work at officeRemote workFlexible hours
- Women In Bio seeks a Regulatory Affairs Specialist to lead the planning and delivery of regulatory submission dossiers in the United States. You will collaborate with teams across clinical, CMC, quality, and regulatory functions, ensuring timely submissions that align...RegulatoryWork at officeRemote work
- GlaxoSmithKline in Upper Providence, Delaware is seeking a professional to lead Chemistry, Manufacturing and Controls (CMC) regulatory activities for vaccine projects. This position offers the opportunity to significantly influence product lifecycle, ensuring compliance...Regulatory
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