Regulatory Affairs Associate II
Date:
Aug 21, 2025
Location:
Navi Mumbai, India, 400706
Company:
Teva Pharmaceuticals
Job Id:
62484
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.
How you’ll spend your day
- Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market.
- Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders.
- Responsible to keep trackers and database up to date.
- Briefing the regulatory status in different forums associated with cross functional teams.
- Experienced in managing software related to Regulatory Affairs and QMS.
Your experience and qualifications
- Academic Degree/PG and thinking level with a chemical/pharmaceutical background.
- 6+ years of experience in CMC Regulatory Affairs; Europe and International Market preferred.
- Knowledge on EU registration procedures and pharmaceutical regulations.
- Good communication skills (written and oral).
- Interest and capability to work with different software, including Document Management Systems.
- Accurate, able to prioritize and work according to agreed timelines.
- Working independently with a moderate level of guidance and direction.
- Solve complex problems using existing solutions and support.
- Identify & implement process improvements. Team player
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.
