CMC Regulatory Strategy Lead – Global Submissions

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

Job summary

Shionogi Inc. (U.S.) is seeking a Senior Manager, Regulatory Affairs CMC to drive regulatory strategies for CMC components of product development. You will coordinate with cross-functional teams and regulatory authorities to ensure compliant submissions and timely milestones.

In this role, you will oversee preparation of CMC documents for INDs, NDAs, and MAAs, and serve as a key contact for regulators. Hybrid work arrangement with US HQ in Florham Park, NJ applies.

Qualifications

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• 5+ years in regulatory affairs, with CMC focus in pharma.
• Strong understanding of FDA, EMA, ICH guidelines.
• Excellent written and verbal communication for diverse audiences.
• Collaborates effectively with cross-functional teams to meet milestones.
• Detail-oriented with meticulous regulatory documentation review.
• Ability to adapt to changing timelines and priorities.
• Willingness to travel; hybrid work on-site 2–3 days/week in NJ.

Responsibilities

• Develop and implement regulatory strategies for CMC with cross-functional teams.
• Prepare, review, and submit CMC documents for INDs, NDAs, MAAs.
• Act as primary liaison with regulatory agencies for CMC inquiries and meetings.
• Coordinate with R&D, QA, Manufacturing, and Commercial teams to align plans.
• Monitor global regulatory changes and assess impact on development programs.
• Maintain documentation of regulatory activities and submissions.
• Identify risks and develop mitigation strategies with senior leadership.
• Support regulatory meetings and strategic decision-making for CMC.
• Perform other duties as assigned.

Skills

Cross-functional collaboration

Regulatory strategy

Regulatory communication

Attention to detail

Analytical thinking

Adaptability

Project management basics

Education

Bachelor's degree in a scientific field

Advanced degree (MSc/PhD/PharmD) preferred

Job description

Shionogi Inc. (U.S.) is seeking a Senior Manager, Regulatory Affairs CMC to drive regulatory strategies for CMC components of product development. You will coordinate with cross-functional teams and regulatory authorities to ensure compliant submissions and timely milestones.

In this role, you will oversee preparation of CMC documents for INDs, NDAs, and MAAs, and serve as a key contact for regulators. Hybrid work arrangement with US HQ in Florham Park, NJ applies.