Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Regulatory Affairs Associate is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva’s 3rd party client business (Medis), ensuring information flow and provision of supportive documents reaches the clients
The PM is responsible for liaison with Teva’s 3rd party client business (Medis) supply chain, Teva site RA and other relevant functions
How you’ll spend your day
Lifecycle management on specific products for Europe and international market
Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable
Inform, prepare and submit variations either directly to authorities or to Teva’s 3rd party client business (Medis)
Follow up on variation submissions, timelines and approvals, in accordance with agreed procedure as applicable
Compile answers to any deficiency questions from authorities or clients
Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable
Regular status updates to management
Goal setting and follow up together with his/her supervisor
Professional communications with both internal and external stakeholders
Work on other specialized projects as defined by managers of RA
Your experience and qualifications
M Pharm/ MSc: 2 to 3 years of experience in RA
B Pharm/BSc: 3 to 5 years of experience in RA
Minimum one year relevant experience in EU.
Personal Characteristics
Good organization skills
Good communication and presentation skills
Good written and verbal knowledge in English
Strategic thinking and flexibility to adapt to changes
Good team player
Good computer skills
Proactive way of working and able to work independently
Reports To
Manager Regulatory Affairs
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.
