Regulatory Affairs Expert

Actavis is looking for qualified and motivated candidate for the role of

Regulatory Affairs Expert
based in Dupnitsa manufacturing sitе

The Role
The Regulatory Affair Expert has the responsibility of obtaining and maintaining marketing authorizations, by providing regulatory expertise and support Module 3 (CMC section), for EU and International markets.

Main responsibilities:
- Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3)
- Compile dossiers (Module 3 and corresponding QOS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive.
- Respond to queries (from regulatory authorities or clients) concerning dossiers submission or changes. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
- Prepare variation and post-approval change packages and other necessary documents as required by the regulatory post-approval processes
- Maintain the dossier (Module 3 and corresponding QOS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer
- Ensure that the documentation of the Active Substance Master Files is appropriate for the required purpose and targeted countries
- 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
- Review for regulatory compliance the analytical validation, stability or other protocols with regulatory or compliance impact

Main requirements:
- University degree, ideally in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field
- Preferably at least 2 years of experience in the pharmaceutical industry
- Experience in Drug Regulatory affairs and/or Quality and/or in Analytics
- 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 (e.g. priorities) and external (e.g. regulatory environment) change
- Must have an eye for detail and a methodical approach to work
- Computer literacy. Must be experienced in the use of spread sheet and word-processing programs. Specialized software, like Trackwise and Document Management System, will be an asset

The company offers:
- Dynamic and challenging work environment in a highly motivated team of professionals
- Competitive remuneration bound with performanceJob specific training
- Additional benefits as per the company policy
- Opportunity for development in an international companyIncluded transportation from certain locations

If interested, apply via -