Global CMC Regulatory Strategy Lead

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision coverage

401(k)

Job summary

Merck & Co. is seeking a Regulatory CMC Principal Scientist to lead global regulatory strategies for small molecules and peptides. You will drive CMC milestones, prepare submissions, and coordinate with authorities to ensure timely approval and market supply of products worldwide.

You will oversee IND/CTAs and agency background packages, mentor staff, and ensure compliance with global regulations while collaborating across diverse functional teams in a dynamic, international environment.

Qualifications

• B.S. in a biological science, engineering, or related field; advanced degree preferred.
• 5–10 years of pharmaceutical development experience in related fields.
• At least 7 years' experience in Regulatory CMC roles, leading NDA/MAA CTD content.
• Proficiency in English; additional languages a plus.

Responsibilities

• Serve as a CMC Product Lead for new small molecule and peptide products; oversee regulatory milestones.
• Lead Regulatory CMC discussions with regulatory agencies to facilitate review and approvals.
• Provide regulatory leadership and strategy to a matrixed team in developing global CMC strategies and executing submissions.
• Oversee IND/CTA, Agency Background Packages, and Worldwide Marketing Applications.

Skills

Regulatory CMC leadership

Global regulatory strategy

IND/CTA/CTD knowledge

Strong communication

Education

B.S. in biological science or related field

Advanced degree preferred

Job description

Merck & Co. is seeking a Regulatory CMC Principal Scientist to lead global regulatory strategies for small molecules and peptides. You will drive CMC milestones, prepare submissions, and coordinate with authorities to ensure timely approval and market supply of products worldwide.

You will oversee IND/CTAs and agency background packages, mentor staff, and ensure compliance with global regulations while collaborating across diverse functional teams in a dynamic, international environment.