RA Specialist CH 881

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


About us

Group 13
Required technical skills:


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

Additional Skills

  • Knowledge and proven experience with Access Consortium and Project Orbis would be an advantage.
  • Previous experience in a consultancy environment would be an advantage
  • Excellent organisational skills
  • Experience of promotional/non-promotional activities would be an advantage
  • Excellent IT skills/knowledge
  • Excellent communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Personal responsibility for ensuring a high standard of work

RA Specialist CH 881