Specialist - Regulatory Affairs Manager

Job Specific Competencies & Skills

• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations

• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)

• Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally

• Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework

• Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request

• Adherence to agreed timelines and proactive communication of any potential risk to the same

• Project management and documentation skills, proactive communication approach

• Contributor level of experience with RIM, Vault and EDMS RA applications

• Excellent written and spoken English language