Regulatory Affairs International Strategy Manager
We currently have a maternity leave cover for a Regulatory Affairs International Strategy Manager Australia and Canada to join a regulatory team based in Zurich.
- Creation of robust regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc.
- Acts as a single point of contact for all regulatory affairs matters concerning the assigned sub region and/or partner companies
- Plans all regulatory activities with the assigned partner companies/regional Hub and ensures timely execution
- Budget the planned regulatory activities
- Communicates with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels
- Works with the legal department on the regulatory review of existing and establishment of new license agreements
- Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
- Ensures compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, Infrastructure and CMC
Keeps up to date with the latest regulatory requirements with the focus on the key markets (Canada, Australia).
Skills and Requirements:
- Degree in Life Sciences
- 4 to 6 years of experience in Regulatory Affairs
- Good command of English - both written and spoken
- Experience in local Drug Regulatory Affairs in Australia and Canada
- Experience of participation in local industry associations e.g. EFPIA
- Ability to analyze the regulatory requirements, perform comprehensive gap assessments and build effective regulatory strategies
- Project and matrix team management capabilities (direct/indirect people management experience is an advantage)
- Computer literacy: advanced skills in Word, Excel and PowerPoint
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.