Head of Regulatory CMC – Small Molecules & ASO/ADC, Hybrid

Arphia Partners Ltd; Paris; Hybrid; EUR 180,000 - 260,000; Full time

Job summary

Confidential Search in the Paris Region is seeking a Head of Regulatory CMC - Small Molecules to lead the global CMC regulatory strategy for a portfolio spanning small molecules, ASO and ADC assets, from early through late-stage development.

Reporting to the Global Head of Regulatory CMC, this newly created leadership role offers autonomy from day one and a clear path for further growth within the function. The role is based in the Paris region with a hybrid work model.

Qualifications

• Circa 15 years of Regulatory CMC experience.
• Deep small-molecule expertise; ASO/ADC exposure welcomed.
• Experience leading global CMC strategy across late-stage assets.
• Proven track record in simultaneous global submissions (US/EU/Japan/China).

Responsibilities

• Own and evolve the global CMC regulatory strategy across a diverse portfolio.
• Lead and grow a team of Regulatory CMC professionals.
• Represent CMC in interactions with major Health Authorities (FDA, EMA, PMDA, NMPA).
• Shape regulatory strategy for global filings in US, EU, Japan and China.
• Partner with CMC, Technical Operations, Quality and Global Regulatory colleagues.

Skills

Regulatory CMC

Leadership

Global submissions

Team management

Job description

Confidential Search in the Paris Region is seeking a Head of Regulatory CMC - Small Molecules to lead the global CMC regulatory strategy for a portfolio spanning small molecules, ASO and ADC assets, from early through late-stage development.

Reporting to the Global Head of Regulatory CMC, this newly created leadership role offers autonomy from day one and a clear path for further growth within the function. The role is based in the Paris region with a hybrid work model.