Regulatory Affairs PM: Europe & CIS Submissions Lead

Aspen Pharma Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Aspen Pharma Group is seeking an experienced Regulatory Affairs Project Manager to coordinate regulatory submissions across Europe and CIS. You will liaise with many departments, manage submission plans, monitor changes in regulations, and drive timely registrations.

The role requires proactive governance, KPI tracking, and continuous improvement of regulatory processes. Based in Ireland, you will report to the Head of Regulatory Affairs Europe and support a broad portfolio of products, ensuring

Qualifications

• High-level degree in life sciences or pharmacy.
• 3–5 years in regulatory within pharma.
• Proficient English language skills.

Responsibilities

• Coordinate regulatory operations for decentralised submission team.
• Represent RA in operational/regulatory projects.
• Consolidate regulatory intelligence across EU and CIS.
• Support registration strategy and monitor regulatory changes.
• Introduce new projects to the regulatory submission team.
• Communicate project status to local affiliates.
• Ensure on-time submissions and documentation readiness.
• Monitor timelines and liaise with stakeholders and providers.
• Raise regulatory risks and provide assessments.
• Maintain KPI trackers and regulatory records.
• Perform tasks in line with internal timelines and QMS.

Skills

Regulatory submissions coordination

Project management

Cross-functional collaboration

Regulatory intelligence

Stakeholder management

English proficiency

Education

BSc/MSc/PhD or Pharmacist in Life sciences

Job description

Aspen Pharma Group is seeking an experienced Regulatory Affairs Project Manager to coordinate regulatory submissions across Europe and CIS. You will liaise with many departments, manage submission plans, monitor changes in regulations, and drive timely registrations.

The role requires proactive governance, KPI tracking, and continuous improvement of regulatory processes. Based in Ireland, you will report to the Head of Regulatory Affairs Europe and support a broad portfolio of products, ensuring