Regulatory Affairs Specialist
Entry (0-2 years)
English - Advanced
The Regulatory Affairs Specialist has the responsibility of obtaining and maintaining marketing authorizations, for Romanian market.
- Support on registration procedures to follow for the submission of Marketing Authorizations (MA) for Teva portfolio products
- Submissions dossier preparation with all national information required, (local review, cover letters, applications forms, fees payment, etc.)
- Submission and execution of national applications and national variations to local regulatory Authorities for MAs.
- Prepare the artworks for the company's products.
- Works with cross functional teams to deliver supporting documentation.
- Keep informed about local legislation and changes in the regulatory environment.
- Assist and provide necessary documents during audits and inspections of affiliates including distributors/vendors/3rd party , if needed
- University degree, ideally in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field
- Preferably 1 - 2 years of experience in the multinational pharmaceutical companies as Regulatory Affairs Specialist
- Good communication skills (both written and verbal English) and interpersonal skills
- Organized with good time management skills
- Pro-active and result oriented
- Able to adapt and respond to internal (. priorities) and external (. regulatory environment) change
- Must have an eye for detail and a methodical approach to work
- Computer literacy(MS Excel, MS PowerPoint, etc.). Must be experienced in the use of spread sheet and word-processing programs. Understanding of regulatory tracking databases
If this sounds like the right opportunity for you, send us your CV in English.
Please kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.