Global Regulatory CMC Lead Scientist
Merck
Merck in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and implement regulatory strategies for pharmaceutical products. The role focuses on CMC dossiers, global submissions, and coordination with manufacturing partners to ensure regulatory conformance. The candidate will lead documentation, authoring, and reviews for regulatory submissions, and manage risk assessment and milestone delivery across the product lifecycle in a global environment. #J-18808-Ljbffr Merck
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Lead Scientist in Rahway, NJ vacancy
$117k - $184.2k
Job DescriptionSENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition... ...Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker)... ...and execute robust, phase-appropriate global Regulatory CMC strategies for drug-...RegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ2 days ago$156.9k - $247k
...Description We are seeking a Principal Scientist to join our Separations... ...roadmaps aligned with CMC needs. Talent development and... ...reliable laboratory operations, regulatory compliance, and continuous capability... ...10/30/2026 Our company is a global health care leader with a...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Inc. in Rahway, NJ seeks an Associate Principal Scientist, Regulatory Affairs to help develop and implement global regulatory strategies for the Vaccine and Infectious... ...with Regulatory Operations, Clinical Safety, Labeling, and CMC, and #J-18808-Ljbffr Merck & Co.Regulatory
- Role Senior Scientist (R3) Regulatory CMC focusing on synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across product... ...development and lifecycle. Responsibilities develop and implement global regulatory CMC strategies for drug-linkers, payloads,...Regulatory
- Scorpion Therapeutics in Rahway, NJ invites a Senior Scientist (R3) to lead Regulatory CMC activities for synthetic moieties of ADCs and bioconjugates... ...product development through lifecycle. You will develop global CMC strategies for drug-linkers, payloads, and peptides,...Regulatory
- Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content. The position requires...Regulatory
$142.4k - $224.1k
...Chemistry, Manufacturing and Control regulatory strategies for assigned... ...pharmaceutical products in accordance with global regulations, guidances and... ...international network on the leading-edge of healthcare... ...Affairs Management, Regulatory CMC, Regulatory Strategy Development...RegulatoryFull timeContract workFor contractorsLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago- Role Associate Principal Scientist/Associate Director in Regulatory CMC focusing on biologics conjugates, primarily ADCs and bio-conjugates, with responsibilities spanning global regulatory strategy development, dossier preparation, and lifecycle management for synthetic...Regulatory
- Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist, Engineering to lead late-stage small molecule manufacturing development, technology transfer, validation, and regulatory filing support across global sites. You will mentor staff, apply QbD and DOE, drive process...Regulatory
- ...Co., Rahway, NJ, seeks a Principal Scientist, Engineering to lead late-stage small molecule programs from... ...transfer to commercial sites, and regulatory filing support while mentoring staff... ...functional collaboration across our global network and strategic decision-making...Regulatory
$173.2k - $272.6k
...integrated stage-appropriate CMC development and commercialization... ...technical, operational & regulatory success or timelines. Analyzes... ...product.Comply with our company's Global and regulatory requirements... ...manner with proven ability to lead complex discussions, influence...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago- ...define and execute packaging strategies that meet global network needs. You will lead cross-functional teams across CMC, collaborate with suppliers, and drive risk... ...development experience, or an MS/PhD with 8 years, and strong knowledge of regulatory #J-18808-Ljbffr Merck & Co.Regulatory
$100k - $130k
...DescriptionBessemer Trust is seeking a Tax Reporting Lead Analyst to join the Data & Tax Operations... ...or cross-border transactions.Monitor regulatory developments affecting NRA withholding... ...with FIS Wall Street Concepts (WSC), FIS Global Plus, Salesforce, Jira, PL/SQL, or...RegulatoryTemporary workWork at officeRemote workBessemer Trust
Woodbridge, NJ6 days ago- Merck & Co., Inc. in Rahway, NJ is seeking an Associate Principal Scientist in Regulatory Affairs to develop and implement global regulatory strategies for VID products. The role involves coordinating with a global liaison, drafting submissions, and guiding regulatory teams...Regulatory
$117k - $184.2k
...Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy for synthetic components... ...Responsibilities Lead regulatory CMC strategy for synthetic moieties of... ...Develop and execute phase-appropriate global regulatory CMC strategies for drug...Regulatory$282.2k
Job DescriptionThe Sr. Principal Scientist, Global Director of Medical Affairs (GDMA) for Head &... ...Management decisions. In addition, the GDMA leads the Medical Affairs input into the... ...medical affairs activities to resolve regulatory, reputational, ethical, and other asset...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago$170k
...professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for...RegulatoryTemporary workMonday to FridayFlexible hours- HireLifeScience seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will be the global point of contact on assigned projects, interacting with FDA, EMA, and affiliates to optimize labeling and shorten...RegulatoryWorldwide
- ...Senior Principal Scientist leading global medical affairs strategy for head and neck cancers and melanoma. Coordinates scientific planning, life cycle management, regulatory engagement, and oversight of regional medical affairs teams across oncology. Responsibilities...Regulatory
Merck
Rahway, NJ8 days ago $142.4k - $224.1k
...Associate Principal Scientist position leading Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for antibody-drug conjugates and bioconjugates. Responsible for executing global regulatory submissions, managing synthetic moieties compliance, and cross-functional...Regulatory$190.8k - $300.3k
...deep understanding of regulatory expectations for immunology... ...that support global clinical development, product... ...Compound Leaders, and scientists across NDS and/or Preclinical... ...development, and CMC.Demonstrate situational... ...collaborations, and proactively lead internal cross-...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ7 days ago- ...& Co. in Rahway, NJ is seeking a principal LAI formulation scientist to lead the design, development, and lifecycle management of long-acting... ...release mechanisms, and ensure scalable manufacturing, regulatory readiness, and patient-centric delivery throughout development...Regulatory
$173.2k - $272.6k
...animals.We are seeking a Principal Scientist to join our Analytical Commercialization... ...This is an exciting opportunity to lead a highly collaborative team of... ...Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ6 days ago$142.4k - $224.1k
...Description of PositionThe Regulatory Affairs Headquarters Associate Principal Scientist supports products in the... ...work closely with a global liaison(s) to help develop... ...also assist or take the lead in tracking, authoring,... ...Manufacturing and Control (CMC) as well as other...RegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ6 days ago- ...of GDMS Process & Quality Management to lead development, implementation, and oversight... ...management activities. Reporting to the Head of Global Data Management and Standards, this role... ...quality/compliance groups to ensure audit readiness, CAPA #J-18808-Ljbffr Regulatory JobsRegulatory
$173.2k - $272.6k
...This role is a Principal Scientist-level technical... ...parenteral dosage forms. Lead LAI formulation and delivery... ...Non-Clinical, Quality, Regulatory, Manufacturing, and... ...mitigation Contribute to CMC regulatory submissions... ...Experience supporting global regulatory filings and...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex... ...to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate...Regulatory
$142.4k - $224.1k
Job Description Associate Principal Scientist, Regulatory CMC - Biologics (R4) This Associate Principal... ...submissions. In-depth knowledge of global Chemistry, Manufacturing, and Controls... ...to support continued product supply. Lead authoring of clear, concise, and effective...RegulatoryFor contractorsLocal areaFlexible hours- Oncology Imaging Scientific Lead Clinical Imaging Build our future together: The successful candidate will lead the strategy and execution... ...of novel imaging biomarkers. Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging...Regulatory
$255.8k - $402.7k
Job DescriptionOur company is a global health care leader with a diversified portfolio... ...career. The Clinical Director (Principal Scientist) has primary responsibility for the planning... ..., placement, monitoring, analysis, regulatory reporting, and publication.Specifically,...RegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory CMC Lead Scientist. Be the first to apply!
Related searches
- image scientist Rahway, NJ
- health scientist Rahway, NJ
- regulatory scientist Rahway, NJ
- scientist biology Rahway, NJ
- drug safety scientist Rahway, NJ
- lead scientist Rahway, NJ
- principal applied scientist Rahway, NJ
- machine learning research scientist Rahway, NJ
- cell culture scientist Rahway, NJ
- research scientist Rahway, NJ