Drug Regulatory Affairs Manager

Harvey Nash is looking for a Drug Regulatory Affairs Manager for a 5 month project in Switzerland.

You are responsible for:

- Working closely with global and local colleagues from DRA and other relevant line functions to define strategy and execute regulatory Submissions to Swissmedic for Safety Label Updates and new Indications
- Maintaining regulatory dossier of a range of products, including submission of Module 3 CMC packages; compilation and Submission of maintenance submissions
- Keeping renewals up-to-date and submitting applications for renewals if required
- Tracking and documenting regulatory activities in respective tools, trackers and databases in collaboration with team
- Managing printed text material according to the quality standards and timelines set by Swissmedic, internal SOPs and KPIs, and other stakeholders; involving the relevant local and global line functions as appropriate.
- Coordinating the process of artwork creation and approval and performing text comparisons of artwork components, including final release of Ready for Print (RfP) and approval of printed packaging material sheet (PPMS).
- Ensuring that submissions to health authority are done in accordance with Swissmedic regulatory standards and internal standard operating procedures or working practices - within appropriate timeframes, including PSURs, DSURs and RMPs, notifications on marketing and de-registration status of registered products.
- Creating and maintaining the Swiss-specific parts of regulatory dossiers including information for Professionals and Patient and Packaging Information as well as National Succinct Statement
- Supporting integration and re-organizations affecting organizational structures and/or product portfolio as appropriate.
- Ensuring appropriate archiving of regulatory relevant Swissmedic documents, including correspondence.

Requirements

-Fluent or Business fluent in German and English (written and spoken)
- Experience in Regulatory Affairs, Label Changes and CMC submissions
- Experience with Swissmedic

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred). For further details feel free to call me. I am looking forward to receiving your application.