Global CMC Regulatory Scientist — Strategy Lead
Johnson & Johnson Innovative Medicine
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 markets. The role demands strong regulatory knowledge, biologics experience, and the ability to collaborate across cross-functional teams while traveling up to 10% internationally. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead global regulatory strategies for large molecules and drive regulatory submissions across markets. The role partners with CMC teams to ensure lifecycle...Regulatory
- Johnson & Johnson Horsham site seeks a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. You will develop global CMC strategies, lead regulatory dossiers, and provide direction on large molecule programs across markets. Responsibilities include leading...Regulatory
$117k - $201.25k
...the way. Learn more at Principal Scientist (Manager), Global Regulatory Affairs, CMC Purpose: The Principal Scientist... ...developing global CMC regulatory strategies and dossier content plans according... ...The primary responsibility is to lead the CMC regulatory activities...RegulatoryLocal area- ...Medicine in Spring House, PA, is seeking a seasoned Regulatory Affairs professional to support global submissions and interactions with health authorities... ...The role covers IND/CTA/NDA/MAA processes, regulatory strategies, and cross-functional collaboration to ensure timely...Regulatory
- 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
- ...for a Distinguished Scientist, Nonclinical Safety... ...ultimately through global registration.... ...Principal Responsibilities:Lead PSTS project teams... ...and investigative strategies.Accountable for global regulatory nonclinical... ...Manufacturing and Controls (CMC) functions to...RegulatoryFull timeLocal area
- CSL Behring is seeking a Regulatory Leader to drive regional regulatory strategies for assigned products, aligning with the Global Regulatory Affairs Strategy Team and regional health authorities. This role emphasizes collaboration, risk-taking, and timely regulatory outcomes...RegulatoryRelocation
- Merck seeks a Distinguished Scientist (Executive Director) to lead scientific strategy for vaccine drug‑substance... ...Discovery, Development, Regulatory and Commercial Manufacturing... ...vaccines, guide CMC regulatory strategies, and drive global #J-18808-Ljbffr MSD MalaysiaRegulatory
$117k - $201.25k
Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs... ...documents and submission strategies in preparation for those filings... ...of NDA, MAA (and other global filings) as assigned (in collaboration... ...for organizing and leading meetings. Provide regulatory...RegulatoryImmediate startFlexible hours$173.2k - $272.6k
...integrated stage‑appropriate CMC development and commercialization strategy which yields the target... ...long‑term supply. Lead DCT—critically assess all... ...technical, operational & regulatory success or timelines. Analyze... ...Comply with our company's global and regulatory...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Ecolab is seeking a Biopharma Regulatory Strategist to shape and execute regulatory strategies that accelerate growth across Life Sciences and Bioprocessing. You will... ...the full biopharma lifecycle. You will bring deep CMC expertise, and strong business acumen to translate...Regulatory
$210.4k - $331.1k
...as a Distinguished Scientist (Executive... ...drive scientific strategy, advance breakthrough... ...medicines that improve global health.As a key member... ..., enabling CMC development and clinical... ...Manufacturing, Regulatory, and Marketing organizations... ...with leading academic institutions...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- Merck in Rahway, NJ is seeking a Senior Scientist in Analytical Chemistry within the... ...Supply goals. It is a lab-based, regulatory-facing position influencing global manufacturing networks. The incumbent will author procedures, lead investigations, train staff, and ensure...Regulatory
$173.2k - $272.6k
...DescriptionWe are seeking a Principal Scientist to join our DSCS Digital... ...ResponsibilitiesWe are a global biopharmaceutical leader with... ...manufacturing, and controls (CMC) activities across our company... ....The chosen candidate will lead strategy, architecture, and delivery for...Full timeTemporary workFor contractorsLocal areaFlexible hours- ...recruiting for a Principal Scientist, Nonclinical Safety Lead within Preclinical... ...ultimately through global registration.... ...nonclinical safety strategies for different modalities... ...integration of literature, regulatory guidance, and... ...Manufacturing and Controls (CMC) functions to ensure...RegulatoryFull timeLocal area
- ...West Point, PA seeks a Senior Scientist to develop and implement large molecule critical reagent strategies across biologics and vaccines pipelines. You will lead cross‑functional analytical development... ...efforts and interact with regulatory teams to drive lifecycle...Regulatory
- Merck & Co. in West Point, PA, is seeking a Senior Scientist to lead large molecule reagent strategies across the biologics and vaccines pipeline. You will partner with analytical development, regulatory, and quality teams to deliver critical reagent strategies through...Regulatory
$117k - $201.25k
...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function... ...is recruiting for a Manager, Global Labeling Product Leader. This... ...for the following:Lead the development, revision, review... ...participate in the global labeling strategy, including demonstrating an...RegulatoryFull timeLocal areaImmediate startWorldwide$119.77k - $140.9k
...Day One.Job DescriptionSUMMARYThe Digital Collections Email Strategy Lead is responsible for the design, execution, and continuous optimization... ...of applicable laws, regulations, financial services, and regulatory trends that impact default management.- Strong presentation,...RegulatoryFull timeWork experience placementLocal area$210.4k - $331.1k
...Summary Distinguished Scientist (Executive Director)... ...Biotechnologies Process R&D. Lead scientific strategy, advance vaccine... ...Manufacturing, Regulatory and Marketing to accelerate... ...leadership on CMC strategies and regulatory... ...industry, consortia and global health organizations;...RegulatoryFor contractors$213k - $260k
...connected by our shared purpose: leading the fight against MASH.... ...our workforce strategy to ensure we have the right... ...Reporting, the Director, Global Clinical Safety Scientist will play a key role within... ...of submission filings and regulatory responses including but not...RegulatoryMinimum wageFull timeLocal areaFlexible hours$253k - $309k
...connected by our shared purpose: leading the fight against MASH.... ...strengthening our workforce strategy to ensure we have the right talent... ...way.The Senior Director, Global Publications Lead is responsible... ..., compliance, legal, and regulatory affairs to ensure consistent...RegulatoryFull timeFreelanceWork at officeLocal areaFlexible hoursNight shift3 days per week- 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
- ...oversee a divisional compliance team, ensuring regulatory alignment across its technology landscape. You will lead IT compliance strategy for large-scale capital investments and... ...and business units, ensuring operations meet global standards. You will manage a high-...Regulatory
- Merck & Co., Inc. seeks an Associate Director of HCP Strategy for HIV Daily Treatments to lead development of strategy and assets for a high-visibility... ...You will partner with analytics, market research, and regulatory partners to inform data-driven decisions and drive...RegulatoryDaily paid
$156.9k - $247k
...leader, an Associate Principal Scientist/Associate Director, has... ...agencies, and health systems globally.Types of studies executed include... ...provide input into clinical, regulatory, payer/access, marketing and evidence generation strategy and programsIn collaboration with...RegulatoryFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...DescriptionThe Clinical Imaging Scientist (Principal Scientist) leads complex imaging deliverables... ...Scientist (CIS) will lead imaging strategy for approximately 15-25 global clinical trials across early-... ...service providersProvide regulatory-facing imaging expertise to support...RegulatoryFull timeFor contractorsLocal areaRemote workFlexible hours- ...are searching for the best talent for a Vice President, Global Commercial Disease Area Strategy (DAS) Leader, Auto-Antibody, Maternal Fetal and Rheumatology... ...against the Johnson and Johnson Immunology goals. Lead the business development strategy, provide commercial expertise...Local area
$107.6k - $161.5k
...and experienced Senior Scientist/Team Leader - Bioprocess Development to lead downstream process development... ...executing purification strategies that support late-stage... ...across Ecolab’s global Bioprocessing labs to address... ...to support regulatory submissions. Work directly...RegulatoryHourly payMinimum wageLocal area- ...Senior Medical Director, Oncology Safety to lead clinical safety and pharmacovigilance strategies for oncology assets within Global Safety. You will supervise safety data... ...matrix, mentoring colleagues and shaping regulatory deliverables. Hybrid work model with on‑site...Regulatory
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