Director of Regulatory Affairs , Europe & UK
Remote (UK, Ireland, or EU)
About the Opportunity
We are a high-growth, clinical-stage biopharmaceutical firm dedicated to advancing transformative therapies for underserved rare dermatological diseases. To support our expanding clinical pipeline, we are looking for an entrepreneurial, hands-on Director of Regulatory Affairs to lead our European and UK regulatory function.
In this dual-impact role, you will define high-level regional regulatory strategies while staying directly involved in execution, authoring, and operational delivery. Operating within a agile, fast-paced setting, you will be the primary liaison to key competent authorities (EMA, MHRA) and drive submissions across all phases of drug development.
Core Responsibilities
1. Regional Regulatory Strategy
- Formulate and execute regional strategies spanning CMC, clinical, and non-clinical disciplines to support rare disease development.
- Lead strategic interactions with the MHRA and EMA, managing Scientific Advice meetings, protocol assistance, early-access pathways, and Requests for Information (RFIs).
- Drive regulatory filings across the drug lifecycle, including CTAs (under EU CTR via CTIS), IMPDs, Paediatric Investigation Plans (PIPs), orphan designations, and future MAAs.
- Monitor shifting European regulatory landscapes-including post-Brexit regulatory divergence-to provide proactive strategy updates to executive leadership.
2. Hands-On Regulatory Writing & Submissions
- Personally author, edit, format, and QC core regulatory documentation to ensure scientific accuracy and compliance with ICH guidelines.
- Produce key dossier components: EU CTIS filings, UK IRAS applications, CMC modules (2.3/3), Investigator's Brochures (IBs), Risk Management Plans (RMPs), labeling, and clinical trial amendments.
- Validate technical content against source scientific data to ensure audit-ready precision.
3. Operations & Project Execution
- Direct submission timelines, document version control, eCTD publishing workflows, and lifecycle archiving.
- Establish inspection readiness and maintain robust regulatory tracking across all cross-functional projects.
- Oversee relationships with regional vendors, regulatory CROs, and external consultants.
4. Cross-Functional Leadership
- Partner closely with Clinical Operations, CMC, Quality, Pharmacovigilance, and Non-Clinical teams to integrate regulatory requirements early in the development cycle.
- Review critical trial materials, including protocols, Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), to maintain strict GCP compliance.
Candidate Profile
Required Qualifications:
- Education: Advanced degree (PhD, PharmD, MSc, or equivalent) in a relevant Life Sciences discipline.
- Experience: 8+ years of dedicated UK/EU regulatory affairs experience within the biopharmaceutical sector, with proven direct engagement with EMA and MHRA.
- EU CTR Expertise: Deep operational familiarity with EU CTR processes, CTIS submissions, and IMP dossier management.
- Lifecycle Mastery: Demonstrated success managing EU/UK regulatory life cycles, PIPs, and MAA module preparations.
- Mindset: A hybrid approach-capable of setting high-level strategy while enjoying "rolled-up sleeves" regulatory authoring and publishing tasks in a lean corporate environment.
Desirable Skills:
- Prior experience with US FDA regulatory frameworks and submissions is an advantage.
- Direct background in rare disease indications or dermatology.
- Advanced proficiency in eCTD formatting, document management tools, and project management applications.
What We Offer
- Strategic Ownership: High-visibility role offering complete autonomy over European regulatory execution.
- Meaningful Impact: Direct involvement in bringing life-changing treatments to rare disease patient communities.
- Workplace Flexibility: Remote/hybrid working model tailored for top talent based anywhere in the UK, Ireland, or EU.
- Competitive Package: Excellent base salary, incentive structure, and broad professional benefits package commensurate with experience.
