Regulatory Affairs Manager
We are looking for a highly motivated Regulatory Affairs Manager to join a prestigious pharmaceutical company in Australia. This is an amazing opportunity to bring your experience and knowledge to a company that effectively contributes to medicine.
- Support on the strategies and registration procedures to follow for the submission of Marketing Authorisations (MA) for new products
- Submissions dossier preparation with all national information required, finalizing of HQ initiation submissions (local review, cover letters, applications forms, fees payment, etc.)
- Submission and execution of national applications and national variations to local Regulatory Authorities for MAs. Communication with local authorities, e.g. follow-up until approval
- Point of contact with national Health Authorities (HA). HA meetings and HA advice and other possible relations/influence
- Continuous support and guidance with national regulatory intelligence. Input for global development projects and due diligences. Keep informed about local legislation and changes in the regulatory environment
Skills and Requirements
- 4-6 years of work experience, preferably but not limited to regulatory affairs
- Bachelor diploma
- Excellent written and verbal communication skills in English
- Creative and good computer skills: Outlook, Power Point, One Note, Excel,
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.