Lead Regulatory CMC Scientist, Biologics

MSD Malaysia; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement

Paid holidays

Vacation time

Compassionate and sick days

Job summary

MSD Malaysia seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for biologics with a strong track record in IND/BLA submissions.

The role includes authoring submissions, cross-functional collaboration, mentoring team members, and driving regulatory Excellence across programs. Competitive compensation and comprehensive benefits are offered.

Qualifications

• 10+ years of biologics CMC regulatory experience including IND/BLA and post-approval changes.
• Experience with regulatory interactions and agency responses across global submissions.
• Strong ability to lead cross-functional teams and mentor scientists.

Responsibilities

• Prioritize submissions in the authorization process.
• Develop and execute global regulatory strategies for INDs/BLAs.
• Lead authoring of regulatory submissions and responses to agencies.
• Collaborate with partner groups to ensure accuracy and completeness of submissions.
• Mentor Senior Scientists and Scientists on assigned projects.

Skills

Regulatory Affairs

CMC

Biologics

IND/BLA Experience

eCTD

Regulatory Submissions

Regulatory Writing

Leadership

Project Management

Cross-Cultural Communication

Education

B.S. in science/engineering

Advanced degree preferred

Tools

eCTD Tools

Job description

MSD Malaysia seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for biologics with a strong track record in IND/BLA submissions.

The role includes authoring submissions, cross-functional collaboration, mentoring team members, and driving regulatory Excellence across programs. Competitive compensation and comprehensive benefits are offered.