1 Year (FREELANCE) Contract Opportunity: EU Regulatory Affairs - Senior Manager (Biotech)
A leading biotechnology company is seeking a highly experienced EU Regulatory Affairs Senior Manager to support development-stage projects and initial Marketing Authorisation Applications (MAAs) across Europe.
Key Responsibilities:
- Lead and support EU Clinical Trial Authorisation (CTA) submissions and amendments via CTIS.
- Manage Paediatric Investigational Plans (PIPs) and full waivers.
- Prepare for and participate in EMA and national Health Authority meetings, including Scientific Advice.
- Collaborate with cross-functional teams across Europe and Asia.
- Monitor and interpret evolving EU regulatory guidance relevant to clinical development.
Candidate Profile:
- Minimum 7 years of regulatory affairs experience in the pharmaceutical or biotech industry.
- Proven experience with centralised MAAs (NAS), major variations, and scientific advice procedures.
- Background in oncology and biologics is advantageous.
- Experience in small biotech/pharma or CRO environments is preferred.
- Prior involvement with teams based in Asia is a strong asset.
- Has to be based in Spain, Poland or Switzerland.
If you are interested in contributing to impactful regulatory work in a dynamic biotech environment, please get in touch or submit your CV for more information.