Head of Regulatory CMC - Small Molecules,

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

Head of Regulatory CMC - Small Molecules, Paris Region | Hybrid | Confidential Search

A global pharmaceutical group with an ambitious, fast-growing development pipeline is seeking a Head of Regulatory CMC - Small Molecules, to lead the global CMC regulatory strategy for a portfolio spanning small molecule, oligonucleotide (ASO) and antibody-drug conjugate (ADC) assets, from early through to late-stage development.

Reporting to the Global Head of Regulatory CMC, this is a newly created leadership role with genuine autonomy from day one and a clear path for further growth within the function.

What you'll do:

• Own and evolve the global CMC regulatory strategy across a diverse, accelerating portfolio weighted toward oncology and rare disease
• Lead and grow a team of Regulatory CMC professionals, developing future leaders within the function
• Represent CMC in interactions with major Health Authorities (FDA, EMA, PMDA, NMPA) on some of the organisation's highest-profile accelerated programmes
• Shape regulatory strategy for simultaneous global filings across the US, EU, Japan and China
• Partner closely with CMC, Technical Operations, Quality and Global Regulatory colleagues to influence critical development decisions

What we're looking for:

• Circa 15 years' Regulatory CMC experience, with deep small-molecule expertise (additional ASO/ADC exposure welcomed)
• A track record leading global CMC strategy across multiple late-phase assets, including at least one experience at each of the key stages of the full development lifecycle through to approval
• Experience with simultaneous global submissions (US, EU, ideally also Japan/China)
• Recent exposure to an accelerated development programme — oncology and/or rare disease strongly preferred
• Strong Senior Director-level candidates with a pure Regulatory CMC background are also encouraged to apply

Why this role:

A rare opportunity to lead CMC regulatory strategy for a scientifically ambitious, multi-modality portfolio, with real executive visibility and scope to build out a growing function.

This search is being conducted on a strictly confidential basis.