EU Regulatory Affairs, Sr Manager (Contractor)

EPM Scientific; Gijón; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading biotechnology company is seeking a highly experienced EU Regulatory Affairs Senior Manager to support development-stage projects and Marketing Authorisation Applications across Europe. The ideal candidate has at least 7 years of experience in regulatory affairs within the pharmaceutical or biotech industry, and experience with EU Clinical Trial Authorisations and MAAs. This freelance position provides an opportunity to contribute to impactful regulatory work in a dynamic environment.

Formación

• 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.

Responsabilidades

• Lead and support EU Clinical Trial Authorisation submissions.
• Manage Paediatric Investigational Plans and full waivers.
• Prepare for and participate in EMA and national Health Authority meetings.

Conocimientos

Regulatory Affairs Experience

Communication Skills

Project Management

Knowledge of EU Regulations

Descripción del empleo

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.

  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.