Remote Regulatory Affairs Director — EU/UK

Cpl; Dublin; À distance; EUR 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

Flexible remote work

Collaborative culture

Entrepreneurial environment

Résumé du poste

Cpl represents a clinical-stage biopharmaceutical company seeking a Regulatory Affairs Director (UK, Ireland or EU – Remote). You will lead European regulatory strategy, oversee submissions to MHRA, EMA and other authorities, and ensure compliance across development programs.

The role combines strategic leadership with hands-on regulatory writing and operational duties, including CTIS/IRAS submissions, variations, PIPs and MAAs, and regulator interactions.

Qualifications

• Extensive regulatory affairs experience in biopharma/biotech.
• Proven track record with EU CTR (CTIS) and UK MHRA pathways (IRAS).
• Experience with Scientific Advice meetings and MAA preparation is valued.

Responsabilités

• Lead UK & EU regulatory strategy across CMC, clinical, and nonclinical areas.
• Oversee submissions including CTAs, IMP dossiers, variations, PIPs, and MAAs.
• Maintain liaison with EMA, MHRA, and other authorities; manage RFIs and Scientific Advice prep.
• Ensure data integrity and compliance with ICH and regional guidelines.

Connaissances

Regulatory strategy

EU CTR / CTIS

Regulatory submissions

Regulatory writing

Stakeholder management

Formation

Bachelor’s degree in a scientific field

Advanced degree preferred (MSc/PhD/PharmD)

Outils

CTIS

IRAS

Regulatory portals

Description du poste

Cpl represents a clinical-stage biopharmaceutical company seeking a Regulatory Affairs Director (UK, Ireland or EU – Remote). You will lead European regulatory strategy, oversee submissions to MHRA, EMA and other authorities, and ensure compliance across development programs.

The role combines strategic leadership with hands-on regulatory writing and operational duties, including CTIS/IRAS submissions, variations, PIPs and MAAs, and regulator interactions.