Regulatory Affairs Manager
Entry (0-2 years), Middle (2-5 years)
English - advanced
The Regulatory Affairs Manager has the responsibility of obtaining and maintaining marketing authorizations, by providing regulatory expertise, for EU and Romanian market.
- Support on the strategies and 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.
- Translation of job-specific documents (leaflet, summary of product characteristics -SmPC, labels and other documents) from Romanian to English and English to Romanian.
- Prepare the artworks for the company's products.
- Communication with local authorities on specific topics/projects, if needed
- Good knowledge on local and EU legislation. Input for global development projects and due diligences. 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
- Actively interact and provide information, support and advice to Teva’s internal departments/affiliates and clients on technical and regulatory issues concerning registration or post-approval change documents
- University degree, ideally in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field
- Preferably 3- 5 years of experience in the multinational pharmaceutical companies as Regulatory Affairs Associate or Regulatory Affairs Manager
- 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.