Regulatory Affairs Manager

Location
Zürich
Salary
80 - 100 CHF per hour (all incl)
Posted
02 Feb 2021
Closes
26 Feb 2021
Ref
49776
Contact
Jocelyn Blackham
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Jocelyn Blackham is recruiting for a Regulatory Affairs Manager to join a global pharmaceutical company at their site based in Zurich on a contract basis from February to June 2021. This role is offered with a workload of 80%.

The main purpose of the role will be to:
- Independently manage MA lifecycle maintenance for a defined product portfolio, including local impact assessments of global changes, preparation and filing of renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. to ensure national registrations are aligned with global dossier updates and comply with local requirements.
- Ensure compliance of labelling (and mock-ups) with the CCDSs and manage communication to internal and external stakeholders as applicable to ensure timely implementation.
- Maintain global and local regulatory databases and systems to ensure accurate records of regulatory activities and documentation.

Further responsibilities will include:
- Representing Regulatory Affairs for the defined product portfolio in internal cross-functional meetings and projects.
- Participate as an active team member and provide regulatory advice to Market Access
team and project teams as required.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University degree in Pharmacy or other scientific studies
- Previous experience in RA for the pharmaceutical industry
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry in Switzerland
- Previous experience with cardiovascular, diabetes or generic drugs would be beneficial
- Fluent written & spoken German & English / additional national language is a plus (French / Italian)

This is an excellent opportunity to join a leading pharmaceutical organisation.

Please could you send any correspondence in English. Please quote reference 49776 in all correspondence.