Senior Regulatory Scientist — Global CMC Strategy

Merck; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) plan

Hybrid work arrangement

Job summary

Merck is seeking a Regulatory Affairs professional to lead global regulatory strategies for assigned pharmaceutical products. You will author and review CMC submission components for approvals and variations, coordinate with manufacturing divisions and external CMOs, and assess regulatory risks to ensure conformance.

The role requires experience with Veeva and strong communication skills. Hybrid work arrangement in the United States, with salary range reflecting seniority, and eligibility for

Qualifications

• Bachelor's in science, engineering or related field.
• Preferred: Advanced degree; 5+ years pharma experience or up to 3 years managing regulatory submissions for small molecules/vaccines/biologics. Experience with Veeva.

Responsibilities

• Lead global product and project regulatory strategies by identifying global regulatory requirements and evaluating documents for acceptability and risk.
• Develop, author and review CMC submission components for regulatory approvals and variations.
• Coordinate with global CMC, Manufacturing, and external partners including CMOs to ensure compliant change management.
• Assess regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones across product lifecycle.

Skills

Adaptability

BLA

eCTD

Regulatory Strategy Development

Regulatory Submissions

Regulatory Writing

International Regulatory Compliance

Cross-Cultural Awareness

Regulatory Affairs Management

Pharmaceutical Process Development

Technical Writing

Veeva

Education

Bachelor's in science or engineering

Tools

Veeva

Job description

Merck is seeking a Regulatory Affairs professional to lead global regulatory strategies for assigned pharmaceutical products. You will author and review CMC submission components for approvals and variations, coordinate with manufacturing divisions and external CMOs, and assess regulatory risks to ensure conformance.

The role requires experience with Veeva and strong communication skills. Hybrid work arrangement in the United States, with salary range reflecting seniority, and eligibility for