Senior Global CMC Regulatory Lead

Shionogi Inc.; Florham Park (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Shionogi Inc. is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets.

The role collaborates with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising with Health Authorities, and authoring regulatory documents across INDs/NDAs/MAAs.

Qualifications

• Bachelor’s degree in scientific discipline required.
• 5+ years in Regulatory Affairs CMC.
• Global regulatory requirements knowledge.
• Experience with global submissions.
• Experience interfacing with Health Authorities.

Responsibilities

• Lead global CMC regulatory strategies across the product lifecycle.
• Prioritize and execute multiple CMC activities.
• Coordinate timelines across cross-functional teams.
• Review and approve change control documentation.
• Provide regulatory assessment for submissions (INDs/CTAs, NDAs/BLAs/MAAs).
• Author and maintain CMC CTD sections.
• Serve as regulatory liaison with Health Authorities.
• Build relationships across stakeholders.
• Maintain regulatory expertise and provide training.
• Incorporate AI tools into CMC activities.
• Act as regulatory CMC technical expert for teams.
• Resolve importation and customs matters.
• Support labeling activities.
• Manage Establishment Registrations and Drug Listings.

Skills

Regulatory leadership

Scientific writing

Cross-functional collaboration

Regulatory strategy

Risk assessment

Mentoring

Communication

Health authority liaison

Education

Bachelor’s degree in science

Advanced degree preferred

RAC certification

Tools

Veeva Vault

eCTD

Job description

Shionogi Inc. is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets.

The role collaborates with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising with Health Authorities, and authoring regulatory documents across INDs/NDAs/MAAs.