Regulatory Affairs Director
Job description
About the Position
We are seeking a Regulatory Affairs Director to join our client, a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic products for rare dermatological diseases. This role is pivotal in leading the European regulatory strategy, overseeing submission execution, and ensuring compliance across all development programs.
Responsibilities
- 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.
Requirements
- 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.
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.
About the Company
Our client is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic products for rare dermatological diseases. We are committed to advancing treatments for patients in need.
Application
If interested, please send your updated CV to [email protected] Please note: Candidates must have full, unrestricted working rights in Ireland (Stamp 4 or EU passport).
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Cpl is a Global provider of workforce solutions to startup companies, multinationals and SMEs in every sector from Pharmaceuticals to Fund Accounting.Founded in 1989, the Cpl Group now comprises 22 brands spanning more than 41 offices in 11 countries.Cpl’s core goal is to power business growth through people. Each of our Cpl divisions and brands offers innovative, sector-focused solutions across recruitment, outsourcing, training, and consultancy. We offer a combination of scale and industry-expertise across the group with over 300 recruitment consultants dedicated to specific sectors and skillsets, including:• IT• Construction• Science• Customer Support• Engineering• Finance• Retail• Banking• HR• Sales• Administration• Marketing• Supply Chain