Head of Regulatory CMC - Small Molecules,
Company: Arphia Partners
- Location: Paris, France
- Work mode: Hybrid
- Seniority: Executive
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
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
- Proven people-leadership experience
- 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. To find out more, please reach out directly to Ed Jessel at Arphia Partners.
