Regulatory CMC Lead for ADC Drug-Linkers

MSD; Pennsylvania; Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Job summary

MSD in North Wales, PA, seeks a Senior Scientist (R3) Regulatory CMC to lead regulatory chemistry, manufacturing and controls for synthetic moieties of ADCs and bio-conjugates. You will shape global CMC strategies and drive milestones across development and lifecycle.

You will manage regulatory filings, interact with health authorities, and coordinate cross-functional teams to ensure compliant, timely submissions while aligning drug-linker content with overall dossiers.

Qualifications

• Minimum 5 years in Regulatory CMC or relevant pharmaceutical development.
• Experience with drug-linkers, ADCs or bio-conjugates preferred.
• Experience with global regulatory submissions and health authority interactions.

Responsibilities

• Lead regulatory CMC strategy for synthetic moieties within ADC/bio-conjugate projects.
• Prepare and respond to health authority questions and manage filings.
• Coordinate cross-functional teams to align dossiers and timelines.
• Oversee change controls and ensure compliance with regulations and policies.

Skills

Regulatory CMC leadership

Regulatory submissions

Global regulatory interactions

Process chemistry

Bioconjugation/ADC knowledge

eCTD/document coordination

Regulatory compliance

Cross-functional leadership

Education

Bachelor’s degree in science/engineering/biochemistry

Advanced degree preferred

Tools

eCTD systems

Job description

MSD in North Wales, PA, seeks a Senior Scientist (R3) Regulatory CMC to lead regulatory chemistry, manufacturing and controls for synthetic moieties of ADCs and bio-conjugates. You will shape global CMC strategies and drive milestones across development and lifecycle.

You will manage regulatory filings, interact with health authorities, and coordinate cross-functional teams to ensure compliant, timely submissions while aligning drug-linker content with overall dossiers.