Regulatory CMC Lead, Drug-Linkers & Bioconjugates
HireLifeScience
Merck & Co., Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates. You will provide regulatory leadership within Regulatory and cross-functional teams to deliver milestones throughout development and lifecycle. The role requires 5+ years in regulatory CMC or related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions. #J-18808-Ljbffr HireLifeScience
- Merck seeks a Regulatory CMC Lead for the regulatory leadership of the drug-linker component in ADC programs. You will partner with cross-functional teams to deliver milestones through development and lifecycle, ensuring compliance and robust CMC strategies. The role requires...Regulatory
$117k - $184.2k
Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATES Position Description Serve as a Regulatory... ...Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$71.9k - $113.2k
...Job Description Associate Scientist, Process Analytics Lab Lead, Biologics Drug Substance Commercialization Join Our Team as a... ...maintained in compliance with safety, environmental, quality, regulatory, and Process Safety Management requirements. Cross-Functional...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/vaccine development. The role involves designing trials... ...teams, and coordinating statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD or...Regulatory
$173.2k - $272.6k
...Description Looking for an experienced Program Lead for our exciting Tulisokibart asset. This... ...sr. management, and governance meetings; regulatory agency interactions; advisory meeting... ...+ 6 years Pharmaceutical and/or clinical drug development experience. Degree in life...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products Business At GSK, we have bold ambitions... ...to a defined portfolio of marketed drug substances and products (small... ...will provide YOU the opportunity to lead key activities to progress YOUR career...RegulatoryLocal area
- Gwynedd Manufacturing in North Wales, PA, seeks a Compliance Manager to oversee regulatory compliance across manufacturing, distribution, and business operations, including the Gun Control Act, NFA, and ATF requirements. The role supports Federal Firearms License (FFL)...Regulatory
- Merck is seeking a lead for Global Regulatory Affairs and Clinical Safety (GRACS) to manage regulatory and contract activities for business development transactions, including due diligence, drafting and negotiating master and regulatory agreements, and coordinating cross...RegulatoryContract work
$173.2k - $272.6k
...Description Position Summary The-Director, CMC Operations Content Management and Digital... .... This role will partner closely with Regulatory Affairs, CMC, Quality, IT, and global business... ...Management Leadership Define and lead the CMC content management strategy across...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck & Co., Inc. seeks a senior Nonclinical Drug Safety Therapeutic Area Leader (Immunology) to advance immunology programs from discovery... ...and mentor leaders to ensure high‑quality risk assessments and regulatory submissions. We value strong scientific acumen, leadership in...Regulatory
$190.8k - $300.3k
Job Description The Nonclinical Drug Safety (NDS) Therapeutic Area... ..., a deep understanding of regulatory expectations for immunology programs... ..., clinical development, and CMC. Demonstrate situational... ...collaborations, and proactively lead internal cross-departmental initiatives...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- GSK is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for a portfolio of small‑molecule products across global markets. The... ...product life cycles and growth opportunities. You will lead CMC strategy, prepare regulatory submissions, and act...Regulatory
- ...seeks a Senior Director, Group Leader to lead the Quantitative Pharmacology and Pharmacometrics... .... You will drive model-informed drug development strategies, translational PK/... ...selection to inform key development and regulatory decisions. You will oversee a team of QP2...Regulatory
- ...in Rahway, NJ, is seeking a Senior Scientist, Global Labeling Lead to develop, maintain, and implement Core Labeling and US Labeling... .... You will lead cross-functional labeling teams, provide regulatory labeling expertise, and collaborate with Regulatory Affairs to...RegulatoryLocal areaWorldwide
$5,000 per month
.... • May perform the following: o Works in the controlled drugs (narcotics) room. o Works with automated machines to prepack... ...network. Our comprehensive solutions, backed by industry-leading technology and regulatory expertise, ensure accurate medication access, cost...RegulatoryWork experience placementLocal areaFlexible hoursShift workNight shiftWeekend work- ...& Co., Inc. in Rahway, NJ seeks a Senior Scientist, Global Labeling Lead to develop and maintain Core Labeling and US/EU labeling for developmental and marketed products, supporting country regulatory labeling. You will lead cross-functional labeling teams, ensure regulatory...Regulatory
$210.4k - $331.1k
...of utilizing MIDD strategies to advance drug development. This would include translational... ...e.g. QSP, AI/ML) for key development and regulatory decisions. This role provides strategic... .... The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a...RegulatoryLocal areaFlexible hours- ...Drug Safety Associate IResponsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate...RegulatoryContract workLocal areaWorldwide
$18.75 - $25 per hour
...to the people and businesses in our KeyBank communities. As a Lead Teller, you act as a resource in identifying and resolving client... ...Teller scheduling, staffing issues, and branch compliance with regulatory, security, and internal audit controls. At KeyBank, we believe...RegulatoryHourly payDay shift- ...be rescinded if you fail to report to the drug test appointment or fail the test. You... ...Element for this position is: ABILITY TO LEAD OR SUPERVISE. Applicants must meet the... ...higher grade level after meeting all regulatory requirements, and upon the recommendation...RegulatoryPermanent employmentFull timeTemporary workPart timeInterim roleWork at officeLocal areaImmediate startRemote workRelocationRelocation packageShift workNight shift
$131k - $210k
...research and manufacturing facilities. We are looking for a dedicated Lead Architect to join our talented team at our office in Somerset,... ...and/or assigned group staff to assure compliance with legal, regulatory, and IPS project requirements. Protects IPS corporate...RegulatoryFor contractorsWork at officeFlexible hours$18.75 - $25 per hour
...Lead Teller Location: 1017 North Bethlehem Pike - Spring House, Pennsylvania 19477 Job Summary Be a problem solver, trusted... ...Teller scheduling, staffing issues, and branch compliance with regulatory, security, and internal audit controls. At KeyBank, we believe...RegulatoryHourly payWork experience placementShift workDay shift$17 - $20.44 per hour
...Lead Dietary Aide Normandy Farms Estates Category: Food Services Position Type: Full-Time 9000 Twin... ...meal service. Responsible for enforcing all policies and ensuring regulatory guidelines for safe food handling and sanitation are in place....RegulatoryFull timeCasual workImmediate startFlexible hours- ...Drug Safety A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most... ...Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include: Standard Operating Procedures...Regulatory
$230.9k - $384.8k
...SUMMARY The CFC Excellence & Enablement Lead is the strategic leader accountable for defining... ...to include medical, prescription drug, dental and vision coverage. Learn more at... ...to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package- ...Microbiology in the United States. The role focuses on testing drug product and substances for release, in-process, and... ...team. The role requires independence, the ability to lead investigations, and support regulatory submissions and inspections. #J-18808-Ljbffr...RegulatoryShift workWeekend work
- ...to the company's success. As a Lead Teller within PNC's Retail Branch organization... ...employees include: medical/prescription drug coverage (with a Health Savings Account... ...(SAFE Act) and/or the Financial Industry Regulatory Authority (FINRA), which prohibit the...RegulatoryFull timeTemporary workPart timeWork experience placementWork at office
$106.2k - $167.2k
...Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country’s Local Labeling. The Senior Scientist, Global Labeling Lead Is Responsible For developing, maintaining, and implementing Core...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$106.2k - $167.2k
...Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country's Local Labeling. The Senior Scientist, Global Labeling Lead is responsible for: developing, maintaining, and implementing Core...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$137k - $235.75k
...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...primary point of contact for US FDA. Lead the regulatory response team for FDA and... ...experience and understanding of clinical drug development, working with US FDA and global...RegulatoryFull timeLocal areaImmediate startFlexible hours
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