Global Head Regulatory CMC - Paris
PARIS, 75
il y a 2 jours
Arphia Partners are retained on a senior, global HQ appointment for a Global Head of Regulatory CMC.
This is a high-impact leadership role shaping global CMC regulatory strategy from early development through registration, launch, and lifecycle readiness, across a complex, accelerated portfolio.
This role requires deep CMC leadership plus with extensive small molecules experience.
Scope of Role
- Own and drive global Regulatory CMC strategy for a development portfolio, from early stage through global registrations and launch.
- Lead CMC regulatory positioning for IND/CTA through NDA/MAA.
- Act as the senior CMC regulatory interface across major agencies (typically EMA, FDA, PMDA) and guide high‑stakes HA interactions.
- Partner closely with Technical Operations, Quality, CMC, Analytical, Supply Chain, and Project Teams to align strategy, timelines, and execution.
- Provide leadership across complex programs including accelerated development timelines, multiple therapeutic areas, and external partner ecosystems.
- Set standards for submission quality, dossier consistency, risk management, and governance.
What we are looking for (non‑negotiable)
- 15+ years of genuine global (HQ) Regulatory CMC experience within small molecules.
- Proven delivery in complex, accelerated CMC environments, including multiple therapeutic areas, concurrent programs and in all major geographical regions.
- End‑to‑end experience spanning early development through registration and launch.
- Clear evidence of senior stakeholder influence, decision‑making, and leadership in cross‑functional settings.
This role offer the opportunity to be part of a rapidly growing Global CMC function with a portfolio of exciting new products.
Email for a confidential conversation.
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Entreprise
Arphia Partners
Plateforme de publication
WHATJOBS
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