Strategic CMC Regulatory Lead – Hybrid

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

Benefits offered by this job

Hybrid work arrangement

Job summary

Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director.

You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans with development timelines and ensure timely FDA/EMA submissions. The role requires a scientific degree with at least five years in regulatory affairs focused on CMC, plus strong communication and cross‑functional collaboration.

Qualifications

• Bachelor's degree in a scientific or related field; MSc/PhD preferred.
• At least five years in regulatory affairs with a CMC focus.
• Knowledge of FDA, EMA, ICH guidelines for CMC regulatory activities.
• Excellent written and verbal communication; strong cross-functional collaboration.
• Willingness to travel as needed.

Responsibilities

• Collaborate with Senior Director and cross-functional teams to develop regulatory strategies for CMC aspects of product development.
• Oversee preparation, review, and submission of CMC documents for regulatory filings (INDs, NDAs, MAAs).
• Serve as primary contact for regulatory agencies for CMC inquiries, meetings, and submissions.
• Coordinate with R&D, QA, Manufacturing and Commercial to align regulatory requirements with development plans.
• Stay updated on global regulatory requirements and assess impact on development timelines.
• Maintain accurate documentation of regulatory activities and submissions.
• Identify regulatory risks and develop mitigation strategies with stakeholders.
• Support Senior Director in regulatory meetings and assessments.

Skills

Regulatory affairs

CMC regulatory

Cross-functional collaboration

Communication skills

Attention to detail

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director.

You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans with development timelines and ensure timely FDA/EMA submissions. The role requires a scientific degree with at least five years in regulatory affairs focused on CMC, plus strong communication and cross‑functional collaboration.