Global Vaccines CMC Regulatory Lead

MSD Malaysia; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays & vacation

Job summary

Merck & Co., Inc. seeks an Associate Principal Scientist to lead global regulatory strategies for vaccines; oversee CMC submission components for regulatory filings; and coordinate with internal and external partners to ensure compliance across the product lifecycle.

The role emphasizes cross-functional leadership, strong communication, and regulatory writing within a hybrid, U.S.-based environment at multiple facilities including Rahway, NJ, and North Wales, PA.

Qualifications

• Bachelor's in science, engineering, or related field; advanced degree preferred.
• 5+ years pharmaceutical regulatory experience; or up to 3 years managing regulatory submissions for small molecules/vaccines/biologics.
• Experience with eCTD, global regulatory requirements, and regulatory strategy development.

Responsibilities

• Lead global regulatory strategies for products across lifecycle.
• Develop and review CMC submission components for variances, MAA/BLAs, and annual reports.
• Collaborate with CMOs and internal teams to ensure regulatory conformance.

Skills

Regulatory strategy

CMC regulatory

eCTD

Regulatory writing

Cross-functional leadership

Veeva

Regulatory submissions

Regulatory affairs management

Strategic thinking

Technical writing

Education

Bachelor's in science, engineering or related field

Advanced degree preferred

Tools

Veeva

Job description

Merck & Co., Inc. seeks an Associate Principal Scientist to lead global regulatory strategies for vaccines; oversee CMC submission components for regulatory filings; and coordinate with internal and external partners to ensure compliance across the product lifecycle.

The role emphasizes cross-functional leadership, strong communication, and regulatory writing within a hybrid, U.S.-based environment at multiple facilities including Rahway, NJ, and North Wales, PA.