Senior Director, Principal Regulatory Affairs Lead
Company: Barrington James Agency
- Location: United Kingdom
- Work mode: Hybrid
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job Title: Principal Global Regulatory Lead (Senior Director level)
Location: UK (London) or France (Paris). Remote or hybrid
We are partnering with a global specialty pharmaceutical organisation to appoint a Principal Global Regulatory Lead at Senior Director level. This is a high-impact leadership position, responsible for shaping and driving global regulatory strategy across development, registration, commercialisation and lifecycle management for a portfolio of products.
You will work in a matrix environment, partnering closely with cross-functional leaders and regional regulatory teams, and acting as a key point of contact for interactions with health authorities across multiple regions.
The Role
- Lead and direct global regulatory strategies across early and late stage development, registrations and lifecycle activities.
- Provide regulatory leadership into global governance forums and project core teams.
- Drive cross-regional alignment on Global Regulatory Plans and ensure consistent, high-quality submission content.
- Oversee and continuously improve regulatory processes, SOPs, work instructions and training across the function.
- Support regulatory oversight of global clinical trials, including forecasting and budget management for regulatory activities.
- Build strong working relationships with key internal stakeholders (Clinical Development/Operations, Biostatistics, CMC/Manufacturing, Quality, Safety, Commercial, etc.).
- Recruit, mentor and develop senior regulatory talent; line-manage and allocate resources aligned to portfolio needs.
- Represent regulatory strategy in senior forums and promote innovative, risk-aware approaches across the portfolio.
Required Experience
- 15+ years’ experience in pharma/biotech, including 10+ years in Global Regulatory Affairs.
- Demonstrable experience building and executing global regulatory strategy across multiple phases (I–IV).
- Strong track record of engaging and negotiating with major health authorities; confident leading high-stakes interactions.
- Experience delivering submissions across more than one regulatory region (e.g., EU/US and/or other key markets).
- Significant people leadership / line management experience in a matrixed environment.
- Strong regulatory project management capability.
Desirable
- Exposure to multiple modalities (e.g., drug-device combinations, biologics, biosimilars, cell/gene therapies) alongside small molecules.
- Deep familiarity with global regulatory frameworks (ICH, CFR and global best practice) and modern submission requirements.
Why Apply?
- Senior, visible leadership role with genuine global influence.
- Opportunity to shape a global regulatory function (process, capability and talent).
- Broad portfolio exposure and close partnership with key business and development leaders.
- Strong compensation package and long-term opportunity in a stable, growth-oriented organisation.
Interested?
Get in touch with the person leading this search, Chris Gibson. cgibson@barringtonjames.com.
