Regulatory CMC Biologics Scientist - Hybrid Lead

MSD Malaysia; Northern (KY); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist, Regulatory CMC Biologics to lead regulatory chemistry, manufacturing and controls efforts for biologics projects. You will drive milestones across development and lifecycle management and develop robust global regulatory strategies.

The role requires 5 years in Regulatory CMC with biologics experience, and offers a hybrid work arrangement with a competitive benefits package including medical, dental, vision, and 401(k).

Qualifications

• 5 years of Regulatory CMC related experience, including biologics or vaccine drug substance/product development, research, or manufacturing.
• Experience with regulatory submissions and documentation in biologics is preferred.
• Strong knowledge of eCTD and global regulatory requirements.

Responsibilities

• Serve as Regulatory CMC Project Lead and drive regulatory milestones from development to lifecycle management.
• Develop robust CMC regulatory strategies and assess global requirements to identify risks.
• Manage execution of regulatory documentation including INDs, BLA/MAA, and post-approval variations.
• Identify and escalate regulatory issues to senior Global Regulatory leaders as needed.

Skills

Adaptability

Biologics

Biology

Biotechnology

Detail-Oriented

Document Coordination

eCTD

Regulatory Affairs Management

Regulatory Communications

Regulatory Compliance

Regulatory Compliance Audits

Regulatory Documents

Regulatory Experience

Regulatory Interpretation

Regulatory Management

Regulatory Operations

Education

Bachelor of Science in a science

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist, Regulatory CMC Biologics to lead regulatory chemistry, manufacturing and controls efforts for biologics projects. You will drive milestones across development and lifecycle management and develop robust global regulatory strategies.

The role requires 5 years in Regulatory CMC with biologics experience, and offers a hybrid work arrangement with a competitive benefits package including medical, dental, vision, and 401(k).