We are looking for a RA Specialist to contribute to regulatory activities performed on the RA Platform. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
Ability to input with Consultancy level expertise for the CH region on a multitude of topics (DACH ideal)
In-depth knowledge of the regulatory framework within the CH region (DACH ideal)
Direct experience with Swissmedic, (BfArM and PEI if possible)
Experience with driving and coordinating Scientific advice meetings
Proven licencing experience and knowledge of Novel medicines, Biologicals, Orphan Drugs and Paediatric considerations.
Proficient with the preparation of Marketing Authorisation Applications for the CH region (DACH ideal)
Experience in the preparation and submission of documentation for post-approval applications in CH region (DACH ideal)
Experience in the preparation and submission of Technical/Site Transfer Applications
Providing support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Proficient in the use of a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget