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Regulatory Affairs Consultant - Post Authorization Activities
Parexel International Corporation
Switzerland - Any Region - Home Based
We are recruiting for a Consultant, Regulatory Affairs with Regulatory Affairs experience in the Switzerland regulatory lifecycle maintenance submissions (variations, renewals…) and post authorization activities.
You will be responsible for:
Provision of strategic advice regarding local regulatory requirements to an internal or external stakeholders
Impact Assessment of CMC and labelling Change Controls and/or CCDS
Module 1 documents preparation
Review of labelling and Artwork in the Country official languages: German, French, Italian
Core packages adaptation to local requirements
Update of section 1 (country specific) for PBRERs
Review of final published submission package
Package Submission to Health Authority (includes Requests for Information)
Updates to local compendia/HA websites
Liaison with Local Country Offices (client)
Liaison with internal Global Regulatory Affairs team
Liaison with Health Authority
Translation ≤1000 words (cover letter/application form/letter from Health Authority…) QualificationsExperience and Qualifications Required:
- Several years of experience working for a CRO, within regulatory lifecycle maintenance and post authorisation activities
- Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
- Fluent business English
- Desirable: Additional language skills: German, Italian, French (at least 2)
Job posted: 2021-10-02