CMC Regulatory Strategy Lead

Shionogi Inc. (U.S.); Florham Park (NJ); Hybrid; USD 140,000 - 170,000; Full time

Job summary

Shionogi Inc. is seeking a Senior Manager, Regulatory Affairs CMC to provide strategic leadership for CMC regulatory activities and ensure alignment with pipeline objectives.

You will collaborate with cross-functional teams and regulatory authorities to drive compliant submissions and timely product development. Based at our Florham Park, NJ site, this hybrid role requires 5+ years in regulatory affairs focused on CMC, strong communication, and the ability to manage INDs, NDAs, and MAAs through

Qualifications

• 5+ years of experience in regulatory affairs, with focus on CMC in pharma.
• Strong understanding of FDA, EMA, ICH guidelines for CMC development.

Responsibilities

• Collaborate on regulatory strategies for CMC across development stages.
• Oversee preparation and submission of CMC documents (INDs, NDAs, MAAs).
• Serve as primary contact with regulatory agencies for CMC inquiries.
• Coordinate with R&D, QA, and Manufacturing to align regulatory needs.
• Stay current on global CMC requirements and guidance.
• Maintain documentation and records of regulatory activities.

Skills

Regulatory affairs

CMC

Cross-functional collaboration

Regulatory strategy

Communication

Documentation

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Shionogi Inc. is seeking a Senior Manager, Regulatory Affairs CMC to provide strategic leadership for CMC regulatory activities and ensure alignment with pipeline objectives.

You will collaborate with cross-functional teams and regulatory authorities to drive compliant submissions and timely product development. Based at our Florham Park, NJ site, this hybrid role requires 5+ years in regulatory affairs focused on CMC, strong communication, and the ability to manage INDs, NDAs, and MAAs through