JO-2609-568854
Regulatory Affairs Director (UK, Ireland, or EU — Remote)
- Employment Type: Full-Time, Permanent
- Reports To: VP, Global Head of Regulatory Affairs
Our client is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic products for rare dermatological diseases. They are seeking a strategic Director of Regulatory Affairs to lead the European regulatory strategy, oversee submission execution, and ensure compliance across all development programs.
You will serve as primary regulatory contact with the MHRA, EMA, and other competent authorities, while simultaneously handling hands-on operational tasks.
What You’ll Do
UK & EU Regulatory Strategy
- Drive Regional Strategy: Develop and execute UK and EU regulatory strategies across CMC, clinical, and nonclinical areas for our rare disease pipeline.
- Lead Submissions: Oversee regional filings including Clinical Trial Applications (CTAs) under EU CTR, IMP dossiers, variations, PIPs, and future MAA submissions.
- Health Authority Relations: Serve as the primary liaison for the EMA and MHRA. Lead preparations for Scientific Advice meetings and manage responses to Requests for Information (RFIs).
- Regulatory Intelligence: Act as the internal expert on evolving UK and EU guidelines, including post-Brexit divergences, and advise teams on regional impact.
Hands-on Regulatory Writing & Operations
- Author & Review: Personally contribute to the writing, formatting, and quality control (QC) of global regulatory documents.
- System Operations: Manage EU CTR submissions via CTIS and UK submissions via IRAS.
- Document Management: Draft and maintain clinical trial notifications, amendments, CMC modules (Module 2.3/Module 3), labeling, RMPs, PIPs, and Investigator’s Brochures.
- Data Integrity: Ensure all submission content is accurate, cross-checked against source data, and compliant with regional and ICH guidelines.
What You’ll Bring
- Industry Experience: Extensive progressive experience in Regulatory Affairs within the biopharmaceutical or biotech industry.
- Regulatory Track Record: Proven, hands-on experience navigating EU CTR (via CTIS) and UK MHRA pathways (via IRAS). Experience with Scientific Advice meetings and MAA preparation is highly valued.
- Therapeutic Expertise: Background in rare diseases or dermatology is a strong advantage.
- Mindset: A strong balance of high-level strategic thinking and a willingness to handle day-to-day writing and operational tasks in a lean environment.
- Education: Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.); an advanced degree (MSc, PhD, PharmD) is preferred.
What We Offer
- The opportunity to shape the regulatory pathway for much-needed rare disease therapies.
- A collaborative, fast-paced, and entrepreneurial company culture.
- Flexible remote working arrangements within the UK, Ireland, or EU.
If interested - please send your updated CV : [email protected]
Please note : Candidates must have full, unrestricted working rights in Ireland (Stamp 4 or EU passport)
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