Global CMC Regulatory Lead (Senior Manager/AD)

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

Job summary

Shionogi Inc. (U.S.) in Florham Park, NJ, seeks a Senior Manager/Associate Director, Regulatory Affairs CMC to define global CMC regulatory strategies and deliver submission-ready content.

You will partner with cross-functional teams to ensure data integrity and regulatory compliance across the product lifecycle. Responsibilities include leading development of Global CMC regulatory strategies, managing timelines, reviewing change controls, and serving as the primary liaison with Health

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 5+ years (Senior Manager) or 7+ years (Associate Director) of Regulatory Affairs CMC experience.
• Knowledge of global CMC regulatory requirements across product lifecycle.
• Experience with global regulatory submissions (INDs/CTAs, NDAs/BLAs/MAAs).
• Proven ability to communicate and negotiate CMC strategies with cross-functional teams.

Responsibilities

• Lead development of Global CMC regulatory strategies across the product lifecycle.
• Define, prioritize, and execute multiple CMC regulatory activities to avoid critical path delays.
• Coordinate multiple CMC project timelines across cross-functional teams.
• Review and approve change control documentation with regulatory guidance.
• Serve as primary CMC regulatory liaison with Health Authorities.

Skills

Global regulatory strategy

CMC regulatory submissions

Regulatory leadership

Health Authority liaison

Veeva Vault / eCTD knowledge

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

Regulatory systems (Veeva Vault)

Job description

Shionogi Inc. (U.S.) in Florham Park, NJ, seeks a Senior Manager/Associate Director, Regulatory Affairs CMC to define global CMC regulatory strategies and deliver submission-ready content.

You will partner with cross-functional teams to ensure data integrity and regulatory compliance across the product lifecycle. Responsibilities include leading development of Global CMC regulatory strategies, managing timelines, reviewing change controls, and serving as the primary liaison with Health