Consultant - Regulatory Affairs - Post Authorization Activities

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)