Regulatory Affairs Associate I
Navi Mumbai, India, 400706
Who we are
The opportunity
- The Regulatory Affairs Associate is a product 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 the 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 specialised projects as defined by managers of RA
Your experience and qualifications
- B Pharm/ M Pharm
- 1 to 4 years relevant experience in RA with EU & International market
Personal Characterisics
- Good organisation 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
Teva’s Equal Employment Opportunity Commitment