Regulatory Affairs Associate (CMC Lifecycle)

Who we are

As a global leader in generic medicines with a strong innovative portfolio, we are all in for better health.

Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Along with our established presence in generics, we have significant research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products.

Today, our portfolio of around 3,600 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of Teva's quality medicines every day. We invest in research and development of innovative medicines, generic drugs and biosimilars, carrying on the legacy of more than a century of finding new ways to help patients improve their lives. This defines our values as a company and characterizes how we do business and approach medicine.
This defines how we do business and motivates thousands of Teva employees all over the world, every single day.

Learn more at www.tevapharm.com.

In Bulgaria Teva (known as Actavis until 2020) is 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. We believe that each and every one of us should have access to quality medicines that help manage illness, fight infection or simply support overall health. Learn more at www.teva.bg

The opportunity

We are searching for qualified and motivated candidates for the role of Regulatory Affairs Associate (CMC Lifecycle), based in Sofia.

The RA CMC Lifecycle Associate has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of Teva.

How you’ll spend your day

• Actively participate in meetings related to registration procedures or when CMC expertise is needed.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration and respond to queries.
• Actively participate in the change control system and work in line with established processes.
• Prepare the variation packages and other necessary documents as required by the variation process
• Perform regulatory evaluation and assessment of technical documentation
• Contribute to renewal applications or annual reports
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International markets) and pharmacopoeias.
• Support strategic projects such as technical transfers.
• Еnsure that all documents and records pertaining to the RA CMC Lifecycle Department are archived properly. Keep departmental database or other tracking systems up to date.

Your experience and qualifications

•    University degree, preferably be in possession of a master level of education in ‘Regulatory Disciplines’ or in other area, but pertinent with the field.
•    2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry.
•    Knowledge on registration procedures and pharmaceutical regulation.
•    Working independently with a moderate level of guidance and direction.
•    Very good command of English, speaking and writing.
•    Good IT skills.
•    Ability to work in team.
•    Communication skills with internal and external customers.
•    Organisation skills.
•    Accuracy in practice and attention to detail.

Enjoy a more rewarding choice

•    Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
•    Competitive remuneration bound with performance
•    Additional healthcare insurance
•    Transportation allowance and other flexible benefits
•    Flexible working hours and option to work from home as per the company policy
•    Opportunity for development

Make a difference with Teva Pharmaceuticals

If this sounds like the right opportunity for you, send us your CV in English.

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. 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.