CMC Regulatory Scientist — Global Submissions & Strategy
Scorpion Therapeutics
Scorpion Therapeutics in Summit, New Jersey is seeking a Senior Scientist, Regulatory CMC to assist in developing global Chemistry, Manufacturing and Control regulatory strategies. This role manages documentation preparation for submissions, including eCTD format, and supports CMC modules and updates related to clinical trials and marketing applications. The ideal candidate will have significant experience in regulatory affairs, an educational background in life sciences, and strong organizational skills necessary for meeting tight deadlines. #J-18808-Ljbffr Scorpion Therapeutics
- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal...Regulatory
- Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products... ...eCTD format. This role supports submission strategies for CMC modules and...Regulatory
- ...is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the... ...role involves supporting the global product team in developing registration strategies for product approvals in both the... ...their expertise, manage submissions, and develop timelines in coordination...Regulatory
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- ...Therapeutics in Madison, New Jersey is seeking a GRS-CMC Director to oversee regulatory submissions and lead multifunctional teams. The successful candidate... ...regulatory directions and ensure compliance with global guidelines while managing submitting processes. Qualified...Regulatory
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...CSRs) and clinical portions of regulatory documents (e.g., IB, DSUR,... ...contribute to regulatory submission) Degree Requirements Degree... ...military needs and an annual Global Shutdown between Christmas and... ...Senior Manager, Global Clinical Scientist - Psychiatry #J-18808-...RegulatoryHourly payFull timeTemporary workPart timeSummer workFlexible hoursShift work$173.39k - $210.11k
## Senior Manager, Global Clinical Scientist - PsychiatryMadison - Giralda - NJ - USFind out how well... ...(CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan... ...responses and contribute to regulatory submission.)**Degree Requirements*** Degree in Life...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- GRS-CMC Director (Cell Therapy) Responsibilities Develop... ...and communicate strategic regulatory direction based on global guidelines and experience. Prepare/oversee CMC submissions; ensure thoroughness, completeness... ...issues; communicate strategy/risks to senior leadership...RegulatoryFlexible hoursShift work
$190.8k - $300.3k
...Job Description Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under general supervision... ..., and Controls (CMC) regulatory strategies for our organization's biologics... ...for the leading the preparation and submission of CMC sections for commercial or...RegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...Initial Therapeutics, Inc. is seeking a Global Labeling Strategist in Morristown, NJ or Cambridge, MA. You will lead the global labeling strategy and ensure compliance with regulatory standards for assigned products. Your role involves collaboration with cross-functional...Regulatory
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## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind... ...direction based on global regulatory guidelines and experience... ...oversee preparation of CMC submissions while ensuring thoroughness,... ...effective global regulatory strategies in coordination with clinical...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$182k - $346k
...advocate strategic positions for CMC regulatory/CMC issues with cross... ...staff to develop robust product strategies that integrate CMC... ...analyze trends and optimize submission and response strategies. Oversee... ...regulatory CMC trends across global markets, ensuring proactive...RegulatoryFull timeLocal area- ...Associate Director in the Regulatory Affairs CMC Department. The successful... ..., and post-authorization submissions for biological substances... ...development of the Regulatory CMC strategy, content, and submission... ...to local and / or global process improvements, which...RegulatoryContract workLocal area
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$173.2k - $272.6k
...role is a Principal Scientist-level technical leadership... ...and development strategy across the portfolio... ...-Clinical, Quality, Regulatory, Manufacturing, and... ...Contribute to CMC regulatory submissions and health authority... ...Experience supporting global regulatory filings and...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...visit Job Description This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline...RegulatoryLocal area
- ...reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. Position Summary / Objective Support Medical Safety Assessment...RegulatoryWorldwide
$182k
...abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...RegulatoryLocal areaWorldwide- Sanofi is seeking a Global Regulatory Lead in Morristown, NJ, responsible for developing and executing global regulatory strategies for oncology products. Candidates should have significant regulatory affairs experience along with investigative and strategic thinking skills...Regulatory
$117k - $184.2k
Job Overview Our company, a global health care leader in the... ...pharmacology trials, including regulatory submissions. Interact with Clinical,... ...discovery and development strategy. Develop individual protocols... ..., and interpretation from scientists, clinical monitors,...RegulatoryFor contractors- ...Associate Director to lead the Health Authorities team in Summit, NJ. The ideal candidate will have substantial experience in regulatory submissions and managing staff. Responsibilities include preparing clinical sections for submissions, leading stakeholder engagement,...RegulatoryFlexible hours
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$130k - $165k
Alfasigma S.p.A. in Morristown, NJ is hiring for a regulatory position focusing on low complexity programs. Responsibilities include developing regulatory strategies, supporting IND/CTA submissions, and ensuring compliance with regulatory requirements. The ideal candidate...Regulatory- ...advocate strategic positions for CMC regulatory/CMC issues with cross... ...staff to develop robust product strategies that integrate CMC... ...analyze trends and optimize submission and response strategies.... ...regulatory CMC trends across global markets, ensuring proactive...RegulatoryLocal area
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- ...Senior Clinical Scientist Location: Cambridge, MA About... ...with quality and regulatory standards. Join the engine... ...for health authority submissions and contribute to regulatory strategy Build and maintain relationships... ...record managing complex global projects Experience...Regulatory
- ...and share local insight to deliver true global perspectives. Job Description This position... ...assist the global clinical development, regulatory, and safety to continually assess and... ...and inform key stakeholders to implement strategies to minimize risk and proactively partner...RegulatoryLocal areaImmediate start
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