Teva Jobs

Regulatory Affairs Expert

Date: Apr 10, 2024

Location:

Dupnitsa, Bulgaria, 2600

Company: Teva Pharmaceuticals

Job Id: 54714

Who we are

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 Bulgaria, we are the largest employer in the pharmaceutical industry with near 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. After the acquisition of Actavis by Teva Pharmaceuticals, in Bulgaria we are operating under the Teva brand.

Currently we are looking for а qualified and motivated candidate for the role of Regulatory Affairs Associate , part of the Registration Documentation Department based in Dupnitsa manufacturing site .

The opportunity

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.

How you’ll spend your day

• 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.

Your experience and qualifications

• 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

Enjoy a more rewarding choice

• 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 Sofia, Pernik, Kyustendil, Blagoevgrad

Make a difference with Teva Pharmaceuticals

All personal data is protected by law and will be treated in confidence.

Only short-listed candidates will be contacted.

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran