Sr Regulatory CMC Biologics Scientist - Global Strategy

Merck; Cambridge (MA); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck is seeking a Senior Scientist (R3) REGULATORY CMC BIOLOGICS to lead Regulatory CMC activities for biologic projects in a cross-functional environment. You will drive regulatory strategy, ensure timely milestones, and manage highly regulated documentation.

Responsibilities include leading documentation for INDs/BLAs and global submissions, proactively addressing health authority questions, and maintaining strict compliance with regulatory standards across development and post-approval

Qualifications

• B.S. in a science, engineering, or related field; advanced degree preferred.
• 5 years of Regulatory CMC experience in biologics or related field.
• Experience in regulatory submissions and health authority interactions.

Responsibilities

• Serve as Regulatory CMC Project Lead and provide leadership within Regulatory and cross-functional teams for assigned biological projects.
• Develop robust regulatory CMC strategies and execute global regulatory requirements; identify potential risks.
• Manage execution of CMC documentation for INDs, BLAs, MAAs, variations, and health authority responses.
• Identify, communicate, and escalate regulatory issues to Global Regulatory and CMC management as needed.
• Conduct all activities with a strong focus on compliance.

Skills

Regulatory CMC

Biologics

eCTD

Documentation Coordination

Regulatory Communications

Cross-functional Leadership

Education

B.S. in science or engineering

Job description

Merck is seeking a Senior Scientist (R3) REGULATORY CMC BIOLOGICS to lead Regulatory CMC activities for biologic projects in a cross-functional environment. You will drive regulatory strategy, ensure timely milestones, and manage highly regulated documentation.

Responsibilities include leading documentation for INDs/BLAs and global submissions, proactively addressing health authority questions, and maintaining strict compliance with regulatory standards across development and post-approval