Regulatory Affairs Specialist needed for well established pharmaceutical company based in Basel, Switzerland.
Our client, one of the largest and most well established pharmaceutical companies in the world, are currently looking for a Regulatory Affairs Specialist to join their team based in Basel, Switzerland.
Working as a Regulatory Affairs Specialist, you will provide Regulatory support to the company in order to obtain Marketing Authorisations for commercial products as rapidly as possible and to maintain these authorisations and provide input into all stages of development and develop strategies to ensure a complete and rapid development.
Reporting to the Regulatory Affairs Manager or Head of Franchise, the main activities involved with this Regulatory Affairs Specialist job include the following:
- Prepare, coordinate and having responsibility for the preparation of regulatory submissions such as clinical trials applications, variations, renewals, support for marketing applications etc. (under the general guidance of their supervisor).
- Participate in the approval of promotional material as required and helping to resolve external medical/technical enquiries, when required.
- Sit on designated working teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and to develop regulatory strategies.
- Aid in the maintenance of the departmental archive of administrative and technical documentation according to internal procedure.
The successful candidate for this position will be educated to a minimum degree level in a relevant field of expertise, along with 2-3 years work experience within Pharmaceutical Regulatory Affairs. In addition to this, the following skills and competencies are required for this Regulatory Affairs Specialist job:
- Knowledge of regulatory procedures and requirements.
- Working knowledge of electronic tools/systems.
- Advanced level in both written and oral English.
- Ability to work in an autonomous manner and manage his/her time.
- Good communication skills and culturally aware.
- Experience in participating in Cross-Functional teams
If you would like to hear more about this Regulatory Affairs job, please contact Jonathan Hart-Smith on 01438 743047 or email firstname.lastname@example.org.
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