Regulatory Affairs Director

Uniphar Group

Dublin, Ireland
Hybrid
8+ years regulatory affairs experience
European regulatory frameworks expertise
Health authority engagement skills
Uniphar Group is seeking a Regulatory Affairs Director in Dublin, Ireland, responsible for overseeing regulatory strategies and operations for unlicensed medicines and commercial product launches across Europe. The ideal candidate will have extensive experience in regulatory affairs, particularly with EU regulations, and possess strong leadership and communication skills

Job Summary

  • The Director of Regulatory Affairs is responsible for defining regulatory strategies and operations related to unlicensed medicines and early access programs across Europe.
  • This role requires proactive engagement with EU/EEA health authorities to manage submissions and ensure timely patient access to critical therapies.
  • Uniphar offers a hybrid working philosophy with flexibility to accommodate global time zones and a culture built on people-first values and entrepreneurial spirit.

Matching Summary

Match Score: 85

Uniphar Group is seeking a Regulatory Affairs Director in Dublin, Ireland, responsible for overseeing regulatory strategies and operations for unlicensed medicines and commercial product launches across Europe. The ideal candidate will have extensive experience in regulatory affairs, particularly with EU regulations, and possess strong leadership and communication skills.

Skills & Requirements

Must-have

  • 8+ years Regulatory Affairs experience
  • European regulatory frameworks expertise
  • Health authority engagement skills
  • Unlicensed medicines pathway knowledge
  • Commercial product launch leadership
  • GMP/GDP compliance management

Nice-to-have

  • Orphan medicine or oncology background
  • HTA and pricing reimbursement experience
  • Distributed team leadership capability
  • Strong business acumen for growth
  • Biotech client facing experience

Key Requirements

  • Advanced degree in life sciences (PharmD, MSc, PhD, MD)
  • 8+ years experience in pharmaceutical Regulatory Affairs
  • Proven track record leading commercial launches in Europe

Work Rights

Not specified

Tailored Resume

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