Global Vaccines CMC Regulatory Strategist

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck seeks a Regulatory Affairs professional to lead global regulatory strategies and author/review Chemistry, Manufacturing and Control submission components for approvals and variations.

You will liaise with Manufacturing, QA, and external partners to ensure regulatory conformance, assess risks, and drive milestone delivery across the product lifecycle. Strong eCTD, BLA/NDA experience and Veeva are required.

Qualifications

• Bachelor's in science, engineering, or related field; advanced degree preferred.
• 5+ years pharma regulatory experience or up to 3 years managing CMC submissions.
• Experience with Veeva and regulatory information management.

Responsibilities

• Lead global product and project regulatory strategies and assess risks.
• Develop and review CMC submission components for approvals and variations.
• Liaise with external partners including CMOs to ensure regulatory conformance.
• Assess regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones across the product lifecycle.

Skills

Regulatory Strategy Development

Regulatory Submissions

eCTD

BLA

Cross-Cultural Awareness

Technical Writing

Regulatory Writing

Strategic Thinking

Regulatory Affairs Management

Education

Bachelor's in science/engineering or related field

Tools

Veeva

Job description

Merck seeks a Regulatory Affairs professional to lead global regulatory strategies and author/review Chemistry, Manufacturing and Control submission components for approvals and variations.

You will liaise with Manufacturing, QA, and external partners to ensure regulatory conformance, assess risks, and drive milestone delivery across the product lifecycle. Strong eCTD, BLA/NDA experience and Veeva are required.