Teva Pharma Jobs – BPharma & MPharma Apply For Regulatory Affairs Post
Regulatory Affairs Associate I
Date: Nov 29, 2023
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 52746
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 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 siteRA 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 a 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 -3 years of experience in RA
- B Pharm/BSc: 5+ years of experience in RA
- 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
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