Senior Global CMC Regulatory Strategy Lead

Shionogi Inc. (U.S.); Florham Park (NJ); Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

Shionogi Inc. (U.S.) is seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets.

The role partners with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. You will lead cross‑functional teams, manage timelines, and provide regulatory guidance for submissions, ensuring data integrity and health authority alignment.

Qualifications

• Bachelor’s degree required in a scientific field; advanced degree desirable.
• Minimum 5 years (Sr Manager) or 7+ years (Assoc Director) in Regulatory Affairs CMC.
• Experience with global regulatory submissions (INDs/CTAs, NDAs/BLAs/MAAs) and post‑approval lifecycle.

Responsabilités

• Lead development of Global CMC regulatory strategies across the product lifecycle.
• Define, prioritize, and execute multiple CMC regulatory activities and elevate decisions when needed.
• Track and coordinate CMC project timelines across cross‑functional teams for timely submissions.
• Review and approve change control documentation with regulatory expectations and data support.
• Provide regulatory assessment and guidance on CMC documentation for submissions; ensure alignment with Health Authority expectations.
• Author and maintain CMC CTD sections (INDs/IMPDs, NDAs/MAAs/NDs, DMF/ASMF) across lifecycle.
• Serve as primary CMC regulatory liaison with Health Authorities; guide agency communications.
• Build trusted relationships with stakeholders across supply chain, manufacturing, QA, and CMOs.
• Maintain expertise in evolving CMC regulatory requirements and provide training as needed.
• Incorporate AI-driven tools into CMC regulatory activities with traceability and verification.
• Mentor and develop others; travel ~10% domestically/internationally; commutable to Florham Park, NJ.

Connaissances

Regulatory writing

Regulatory strategy

Cross-functional collaboration

Leadership

Regulatory affairs

Mentoring

Formation

Bachelor's degree in a scientific discipline

Advanced degree preferred

RAC a plus

Outils

Veeva Vault

eCTD

Description du poste

Shionogi Inc. (U.S.) is seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets.

The role partners with technical, quality, supply and program teams to deliver submission-ready CMC content with a risk-based approach. You will lead cross‑functional teams, manage timelines, and provide regulatory guidance for submissions, ensuring data integrity and health authority alignment.