Global Regulatory CMC Lead Scientist

Merck; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and implement regulatory strategies for pharmaceutical products. The role focuses on CMC dossiers, global submissions, and coordination with manufacturing partners to ensure regulatory conformance.

The candidate will lead documentation, authoring, and reviews for regulatory submissions, and manage risk assessment and milestone delivery across the product lifecycle in a global environment.

Qualifications

• Bachelor's in science, engineering or related field; advanced degree preferred.
• Experience in regulatory affairs for pharma or biologics.
• Strong communication, documentation and cross-functional collaboration.

Responsibilities

• Lead global regulatory strategies; identify requirements and assess risks.
• Develop and review CMC submissions for regulatory approvals and variations.
• Coordinate with CMOs and internal partners to ensure regulatory conformance.
• Assess regulatory risks and propose mitigation strategies.
• Ensure timely delivery of regulatory milestones across product lifecycle.

Skills

BLA regulatory knowledge

eCTD

Regulatory strategy development

Regulatory submissions

Regulatory writing

Regulatory CMC

International regulatory compliance

Cross-cultural awareness

Detail-oriented

Veeva

Strategic thinking

Technical writing

Regulatory affairs management

Pharmaceutical process development

Education

Bachelor's in science or related field

Advanced degree preferred

Tools

Veeva

Job description

Merck in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and implement regulatory strategies for pharmaceutical products. The role focuses on CMC dossiers, global submissions, and coordination with manufacturing partners to ensure regulatory conformance.

The candidate will lead documentation, authoring, and reviews for regulatory submissions, and manage risk assessment and milestone delivery across the product lifecycle in a global environment.