Regulatory affairs specialist Jobs in Affoltern Am Albis

Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to find their next Regulatory Affairs Consultant!

Proclinical is seeking a Regulatory Affairs Consultant to manage regional regulatory activities for biosimilars. In this role, you will coordinate with affiliate regulatory affairs teams to address national regulatory requirements and support product launches. You will also oversee product updates across various countries and ensure compliance with national regulatory processes. This position requires strong collaboration with internal stakeholders, vendors, and medical teams to facilitate regulatory processes effectively.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities :

• Manage regional regulatory affairs activities for biosimilars.
• Coordinate with affiliate regulatory affairs teams to identify and fulfill national regulatory requirements.
• Oversee and manage product updates across multiple countries.
• Build and maintain effective communication with internal stakeholders, vendors, and affiliate regulatory teams.
• Facilitate and oversee national regulatory process steps, including risk minimization measures.

Key Skills and Requirements :