Director Regulatory Affairs

Morgan McKinley; Dublin; Remote; EUR 140,000 - 180,000; Full time

Benefits offered by this job

Remote/hybrid flexibility

Competitive package

Job summary

Morgan McKinley is seeking a Director of Regulatory Affairs to lead Europe and UK regulatory strategy for a clinical-stage biopharma focused on rare dermatology diseases. This remote role involves authoring submissions, liaising with EMA/MHRA, and driving lifecycle management.

The candidate will shape regional strategy, author regulatory documents, ensure inspection readiness, and partner with Clinical Operations, Quality, and Pharmacovigilance in a lean, fast-paced environment.

Qualifications

• 8+ years of dedicated UK/EU regulatory affairs experience within the biopharmaceutical sector, with proven direct engagement with EMA and MHRA.
• Deep operational familiarity with EU CTR processes, CTIS submissions, and IMP dossier management.
• Lifecycle mastery of EU/UK regulatory life cycles, PIPs, and MAA module preparations.

Responsibilities

• Define high-level regional regulatory strategy for Europe and UK across CMC, clinical, and non-clinical disciplines.
• Personally author, edit, format, and QC core regulatory documentation to ensure compliance with ICH guidelines.
• Manage submissions timelines, eCTD publishing workflows, and lifecycle archiving.
• Collaborate with Clinical Operations, CMC, Quality, Pharmacovigilance, and Non-Clinical teams to integrate regulatory requirements early in development.

Skills

Regulatory strategy

Regulatory writing

Cross-functional leadership

Education

PhD/PharmD/MSc in Life Sciences

Tools

eCTD formatting

Regulatory submissions tools

Job description

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.