Proclinical is collaborating with a biotechnology company who is seeking a Senior Manager in EU Regulatory Affairs to support the EU Regulatory Leader in late-stage development projects and Marketing Authorization Applications (MAA). This role requires immediate availability, preferably by early December.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

Support the EU Regulatory Leader in late-stage development projects.Manage EU Clinical Trial Authorization applications and maintenance.Handle centralized MAA (New Active Substance).Conduct centralized or national scientific advice.Prepare for meetings with the European Medicines Agency (EMA) or national health authorities.Develop and modify pediatric investigational plans.

Key Skills and Requirements:

Proficiency in EU Clinical Trial Authorization applications and maintenance.Experience with centralized MAA (NAS) and scientific advice.Ability to prepare for regulatory meetings with EMA or national health authorities.Knowledge of pediatric investigational plans and modifications.Experience in oncology and biologics is a plus.Background in working with small biotech/pharma or CROs is advantageous.Experience supporting or managing teams located in Asia is highly desirable.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.