Global Head of Regulatory CMC | Small Molecules
Company: Arphia Partners
- Location: Paris, France
- Work mode: Remote
- Seniority: Executive
- Employment type: Full-time
- Posted: 2 days ago
- Offer language: English
Job description
Global Leadership Opportunity | Remote with Travel to Paris | Innovative Development Portfolio
We are working with a global pharmaceutical organisation to appoint a Global Head of Regulatory CMC, leading the regulatory strategy for a diverse and increasingly innovative small molecule development portfolio.
This is a senior leadership appointment with genuine influence over the direction of the portfolio, from early clinical development through pivotal Phase II/III programmes, global submissions and marketing authorisation.
Of particular interest is the organisation's focus on accelerated development pathways, where the ability to anticipate regulatory challenges, shape CMC strategy and deliver against ambitious timelines is critical.
We are looking for an established Regulatory CMC leader who brings:
- Extensive Regulatory CMC experience in small molecule development, with particular depth across Phase II/III and global registration. This is a Regulatory CMC appointment, not a Pharmaceutical Development CMC role.
- A proven record of taking products from early development through NDA/MAA submissions, including direct engagement with the FDA and EMA.
- Experience of accelerated development programmes, with a strong understanding of the regulatory strategies required to support expedited approvals.
- Established people leadership, including direct line management of at least five professionals, alongside the ability to develop and lead a high-performing regulatory function.
- The strategic judgement, technical credibility and senior stakeholder influence to operate at global leadership level.
The opportunity offers considerably more than portfolio oversight. You will have the scope to influence regulatory direction, develop organisational capability and play a central role in advancing innovative medicines towards commercialisation.
The role is expected to offer a remote working arrangement, with periodic travel to the organisation's Paris headquarters, providing flexibility without compromising the global leadership remit.
We are particularly interested in speaking with Senior Directors, Executive Directors and Global Heads who have the technical depth, leadership experience and ambition to take on a broader global mandate.
For a confidential discussion, please contact Daniel Bygrave at Arphia Partners.
