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Regulatory Affairs Associate

Date: Oct 13, 2021

Location: Dupnitsa, BG, 2600

Company: Teva Pharmaceuticals

Company Info


Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com. 


In August 2016 Actavis has been acquired by Teva Pharmaceutical. In Bulgaria, we are the largest employer in the pharmaceutical industry, with nearly 1700 employees in the two manufacturing plants (Dupnitsa and Troyan); sales and marketing organization and in a number of global corporate functions based in our country. As a Teva company, in October 2020 Actavis has started the process of re-branding and anticipating the Teva brand. 


We are looking for qualified and motivated candidate for the role of Regulatory Affairs Associate, based in Dupnitsa manufacturing site.

The Role


The Regulatory Affair Associate 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 in Pharmacy, Chemistry, Biology, Biochemistry or another relevant area
•    Background in Drug Regulatory affairs/ Quality/ Analytics spheres
•    Additional experience in the pharmaceutical industry would be preferred
•    Good communication skills in English (both written and verbal)
•    Excellent organizational and time management skills
•    Team player, pro-active and result oriented attitude
•    Ability to adapt and respond to internal and external change (e.g. priorities/regulatory environment) 
•    Eye for details and methodical style of working
•    Computer literacy (ability to work with spreadsheet and word-processing programs) is a must
•    Experience in using specialized software (e.g. Trackwise/ Document Management System) would be an asset

We Offer


•    Dynamic and challenging work environment in a highly motivated team of professionals
•    Competitive remuneration bound with performance
•       Job specific training
•       Additional benefits as per the company policy
•       Opportunity for development in an international company
•       Included transportation from certain locations


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.

Already Working @TEVA?


If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


Teva’s Equal Employment Opportunity Commitment


Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.