Senior Manager, CMC Regulatory Affairs – Hybrid Role

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

Job summary

Shionogi Inc. in Florham Park, NJ, is seeking a Senior Manager, Regulatory Affairs, CMC to support the CMC regulatory program under the Senior Director.

You will coordinate strategic regulatory activities for Chemistry, Manufacturing, and Controls, collaborating with cross-functional teams and regulators to ensure compliance and timely submissions. Responsibilities include developing CMC regulatory strategies, preparing and submitting CMC documents for INDs, NDAs, and MAAs, serving as a liaison

Qualifications

• Bachelor's degree in a scientific or related field; MSc/PhD/PharmD preferred.
• Minimum of five (5) years of experience in regulatory affairs, with a focus on CMC.
• Strong understanding of global regulatory requirements (FDA, EMA, ICH).
• Excellent verbal and written communication; ability to collaborate across functions.
• Willingness to travel; hybrid work on-site 2–3 days/week at our US HQ in Florham Park, NJ.

Responsibilities

• Develop and implement regulatory strategies for CMC across product development.
• Oversee preparation and submission of CMC documents for INDs, NDAs, MAAs.
• Serve as main regulatory contact with agencies regarding CMC inquiries and meetings.
• Collaborate with R&D, QA, Manufacturing, and Commercial to align CMC requirements.
• Stay updated on global regulatory requirements and industry trends.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Regulatory knowledge

Communication skills

Attention to detail

Project management

Ethical conduct

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Shionogi Inc. in Florham Park, NJ, is seeking a Senior Manager, Regulatory Affairs, CMC to support the CMC regulatory program under the Senior Director.

You will coordinate strategic regulatory activities for Chemistry, Manufacturing, and Controls, collaborating with cross-functional teams and regulators to ensure compliance and timely submissions. Responsibilities include developing CMC regulatory strategies, preparing and submitting CMC documents for INDs, NDAs, and MAAs, serving as a liaison