Regulatory Affairs Support
Posted on Mar 17, 2019 by Hobson Prior
This RA Support role will be handling requests and submissions of regulatory files such as product and price certificates for several countries of the region. Support the management of artwork due to changes of legal entities and spin-off of Alcon.
Prepare and submit requests for CPPs (certificate for pharmaceutical product) to Swissmedic in a timely manner. Track submissions
Coordinate and prepare price certificates and statements for markets in EMEA
Interact with Swissmedic and pricing authorities as needed
Coordinate artwork activities in the context of changes of Marketing Authorization Holders and other changes related to the spin-off of Alcon
Support other Regulatory Affairs activities projects related to the spin-off of Alcon
Apply national regulations and guidelines, and company policies, and ensure high ethical conduct.
Vigilance Clause: Jobholder is obligated to report any complaint (e.g. Adverse Event or Quality complaint) within 24 h from the receipt to the Vigilance department in accordance to the valid local SOPs
Previous regulatory/administrative experience in the medtech or pharma industry
Knowledge or abilities of: Communication to and correspondence with authorities and Technical and pharmaceutical affinities
Demonstrates the Novartis Values and Behaviours
Approaches tasks and projects systematically and with analytical thinking
Effectively solves problems
Works precisely, is detail oriented
Autonomous, has mental grasp / is quick minded
Team player, customer focused, communicates effectively
Takes initiative and is committed to excellence, is able to work under pressure, flexible, and willing to learn
Education in Commerce, administration, life science or similar disciplines
2-5 years in administration
Fluent in German and English, both spoken and written (required); French optional but a plus
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.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.