Manager Regulatory Affairs (CMC Lifecycle)
Sofia, Bulgaria, 1407
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 Manager Regulatory Affairs (CMC Lifecycle), based in Sofia.
The Manager RA CMC Lifecycle has the responsibility of obtaining and maintaining marketing authorizations, by managing a small RA CMC team and by providing regulatory expertise and support around the CMC section of regulatory dossiers (module 3), for Teva worldwide.
The Manager further has the responsibility to actively support from CMC-perspective the whole evaluation and execution of projects (such as site transfers, sourcing changes and volume transfers) and liaise with other team members to make sure that timelines are met.
How you’ll spend your day
• Plan Team activities and ensure that they are adequately delegated and that the required resources (including human resources) are available.
• Coordinate time critical regulatory activities of the team in alignment with the manufacturing site’s needs.
• Monitor and report on departmental Key Performance Indicators.
• Carry out managerial responsibilities in accordance with the organization policies and procedures.
• Provide support, direction and coaching to subordinate employees.
• Support recruitment of staff as necessary.
• Drive and support the compilation of up-to-date Modules 3 for new submissions.
• Drive and support the compilation of necessary variations packages for the above-mentioned projects.
• Assess the dossiers (Module 3) suitability for new submissions in EU and International Markets
• Ensure that Change control records are evaluated for regulatory impact in accordance with applicable regional and local regulations.
• Ensure that the variation packages and other necessary documents as required by the variation process are delivered in an appropriate and timely manner.
• Keep up to date with regulatory developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International Markets) and pharmacopoeias.
• Ensure 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 Master in ‘Regulatory Disciplines’ or relevant
• Preferably at least 5 years of experience in CMC and Regulatory Affairs
• Extensive knowledge on registration procedures and pharmaceutical regulation
• Preferably experience in managing a team
• Good communication skills (both written and verbal English) and interpersonal skills
• Organized with good time management skills
• Customer-oriented, pro-active and result oriented mindset
• Able to adapt and respond to internal (e.g. priorities) and external (e.g. regulatory environment) changes
• Must have an eye for detail and a methodical approach to work
• Ability to work in team.
• Must have a GMP mindset in addition to the regulatory one
• Good computer skills
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.
