Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory CMC Lead - ADC Drug-Linkers

MSD Malaysia

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 5+ years in Regulatory CMC with experience in drug-linkers, ADCs, or bio-conjugates, and a strong background in eCTD and regulatory submissions. Hybrid work in San Francisco or Los Angeles is available. #J-18808-Ljbffr MSD Malaysia

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory CMC Lead - ADC Drug-Linkers in North Wales, PA vacancy
  • 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... 
    Regulatory

    HireLifeScience

    North Wales, PA
    1 day ago
  • $117k - $184.2k

    Position Description Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs, providing regulatory leadership within Regulatory and on cross‑... 
    Senior
    Regulatory
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD Malaysia

    North Wales, PA
    3 days ago
  •  ...USA, a BARDS division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/vaccine development. The role involves designing...  ...teams, and coordinating statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD... 
    Senior
    Regulatory

    Merck & Co.

    North Wales, PA
    2 days ago
  • $210.4k - $331.1k

     ...(QP2 Oncology) team as Senior Director, Group Leader...  ...strategies to advance drug development. This would...  ...for key development and regulatory decisions. This role provides...  ..., Group Leader will lead a team of QP2...  ...new modalities such as ADCs and TCEs Team Leadership... 
    Senior
    Regulatory
    Local area
    Flexible hours

    Merck & Co.

    North Wales, PA
    5 days ago
  • Merck & Co. seeks a Senior Director, Group Leader to lead the Quantitative Pharmacology and Pharmacometrics -...  ...Development. You will drive model-informed drug development strategies,...  ...selection to inform key development and regulatory decisions. You will oversee a team of... 
    Senior
    Regulatory

    Merck & Co.

    North Wales, PA
    5 days ago
  • Merck & Co., Inc. 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... 
    Senior
    Regulatory
    Local area
    Worldwide

    Merck & Co.

    North Wales, PA
    5 days ago
  • Merck & 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... 
    Senior
    Regulatory

    Merck

    North Wales, PA
    1 day ago
  • Merck seeks a Senior Specialist in North America GSCM to support Network Strategy and end-to-end transfer design. You will perform capacity...  ..., and risk mitigation across donor and receiving sites, regulatory, quality, and master data teams. The role requires strong cross... 
    Senior
    Regulatory

    Merck

    North Wales, PA
    2 days ago
  •  ...Programmer in the US to support late-stage clinical development projects. You will lead programming tasks, develop analysis datasets, and deliver tables, listings, and figures for regulatory submissions. Responsibilities include coordinating a global programming team,... 
    Senior
    Regulatory

    Merck & Co.

    North Wales, PA
    5 days ago
  • Merck & Co. is seeking a Principal Medical Writer to develop, author, edit, and lead the review of high-quality clinical and regulatory documents across multiple programs. You will collaborate with cross-functional teams and act as a subject matter expert in medical writing... 
    Senior
    Regulatory

    MSD Malaysia

    North Wales, PA
    3 days ago
  • $190.8k - $300.3k

     ...Description The Nonclinical Drug Safety (NDS)...  ...Area Leader (TAL) is a senior scientific leader responsible...  ...deep understanding of regulatory expectations for immunology...  ...development, and CMC. Demonstrate situational...  ...collaborations, and proactively lead internal cross-... 
    Senior
    Regulatory
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    West Point, PA
    2 days ago
  • $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... 
    Regulatory
    Full time
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD

    Upper Gwynedd, PA
    20 hours ago
  • $122k - $212.75k

     ...is recruiting for a Senior Manager, IM R&D...  ...product development, regulatory compliance, data integrity...  ...organizations. Lead strategies for...  ...testing, raw-material, drug-substance and drug-...  ...including CMC development and manufacturing...  ...gene therapies, ADCs, peptides, RNA-... 
    Senior
    Regulatory
    Full time
    Contract work
    Local area
    Immediate start

    Johnson & Johnson Innovative Medicine

    Spring House, PA
    2 days ago
  • $117k - $184.2k

     ...in people and animals. As a Senior Scientist in Process Analytics...  .... Collaborate closely with drug substance and drug product...  ...technical protocols, reports, and regulatory documents in support of...  ...support and guidance to the lab lead and help foster a collaborative... 
    Senior
    Regulatory
    Full time
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD

    Upper Gwynedd, PA
    1 day ago
  •  ...provide biostatistics consulting throughout all phases of drug development, ensuring compliance with regulatory requirements. The ideal candidate will have a Ph.D....  .... The role involves close collaboration with senior management, mentoring junior staff, and presenting findings... 
    Senior
    Regulatory

    INC Research

    King of Prussia, PA
    1 day ago
  • Ecolab is seeking a Senior Scientist/Team Leader - Bioprocess Development to lead a downstream purification team focused on monoclonal antibodies. You will guide...  ..., drive technology transfer, and ensure regulatory-ready documentation while maintaining lab operations... 
    Senior
    Regulatory

    Ecolab

    King of Prussia, PA
    2 days ago
  • Seaton Senior Living, part of Discovery Senior Living, seeks a Nurse Manager to lead health and wellness initiatives within the community. You will coordinate personal...  ...-offs, and ensure staffing levels align with regulatory requirements while maintaining compassionate... 
    Senior
    Regulatory

    Seaton Senior Living

    Chalfont, PA
    1 day ago
  • GAI Consultants is seeking an experienced Senior Project Environmental Specialist to lead siting, permitting, and documentation for electric transmission projects. You will coordinate with clients and regulatory agencies, prepare proposals, estimate costs, and guide quality... 
    Senior
    Regulatory

    GAI Consultants Inc.

    Collegeville, PA
    1 day ago
  •  ...Behring in King of Prussia, PA, seeks a Principal Medical Writer to lead medical writing strategy for one or more clinical Programs, ensuring high-quality, strategically aligned deliverables for regulatory submissions. This role partners with cross-functional teams... 
    Senior
    Regulatory

    CSL Plasma Inc.

    King of Prussia, PA
    3 days ago
  •  ...searching for the best talent for a Senior Scientist, In-vivo CAR-T, to...  ...up of lentiviral vector (LVV) drug product processes from early...  ..., Quality, Manufacturing, and Regulatory teams to ensure alignment on...  ..., Manufacturing, and Control (CMC), Coaching, Consulting, Critical... 
    Senior
    Regulatory
    Local area

    Johnson & Johnson Innovative Medicine

    Spring House, PA
    4 days ago
  • Fidelio Dental Insurance is seeking a Senior Accountant for a full-time, on-site position in Glenside, Pennsylvania. This role is responsible for leading the accounting and financial reporting function, including managing the general ledger, overseeing close processes,... 
    Senior
    Regulatory
    Full time

    Fidelio Dental Insurance

    Glenside, PA
    1 day ago
  •  ...while also supporting teller duties as needed. You will contribute to meeting service and sales targets, engage in cross-functional referrals, and adhere to internal controls and regulatory requirements. Some weekends and travel may be required. #J-18808-Ljbffr Truist
    Senior
    Regulatory
    Weekend work

    Truist

    Jenkintown, PA
    1 day ago
  •  ..., Inc. in the United States seeks a Senior Director in Oncology to lead clinical development strategies for...  ...investigational and marketed oncology drugs. You will work with cross-functional...  ...from early development through regulatory submission. Responsibilities include... 
    Senior
    Regulatory

    Merck & Co.

    North Wales, PA
    5 days ago
  • $107.6k - $161.5k

     ...seeking a passionate and experienced Senior Scientist/Team Leader - Bioprocess Development to lead downstream process development...  ..., and documentation to support regulatory submissions. Work directly...  ...background screens and/or drug/alcohol testing for customer credentialing... 
    Senior
    Regulatory
    Hourly pay
    Minimum wage
    Local area

    Ecolab

    King of Prussia, PA
    2 days ago
  • $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... 
    Senior
    Regulatory
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck

    North Wales, PA
    3 days ago
  • $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... 
    Senior
    Regulatory
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    North Wales, PA
    5 days ago
  • $117k - $184.2k

     ...as a Biologics Conjugation Senior Scientist! We are seeking a...  ...characterization, right first time PPQ and regulatory filings. You will engage...  ...Lab Operations Leadership: -Lead daily lab operations,...  ...Required Skills: Antibody Drug Conjugates (ADC), Bioconjugation,... 
    Senior
    Regulatory
    Contract work
    For contractors
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    West Point, PA
    5 days ago
  • Merck & Co. is seeking a Director, CMC Operations Content Management and Digital Enablement to lead global content management across the lifecycle, partnering with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define strategy and governance. The role emphasizes... 
    Regulatory

    Merck & Co.

    North Wales, PA
    3 days ago
  •  ...Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead QA activities, ensuring cGMP compliance across the site. The...  .... The ideal candidate will have a strong background in GMP, regulatory interactions with FDA, and extensive experience in quality systems... 
    Senior
    Regulatory

    Piramal Pharma Ltd

    Sellersville, PA
    1 day ago
  •  ...Systems & Compliance in Bucks County, PA to oversee site QA systems and ensure cGMP conformity. You will lead audits, CAPA programs, document control, and regulatory interactions to sustain quality and compliance throughout operations. The role requires extensive QA... 
    Senior
    Regulatory

    PPL Healthcare LLC

    Sellersville, PA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory CMC Lead - ADC Drug-Linkers. Be the first to apply!