Regulatory Affairs Associate I
Date:
Sep 5, 2025
Location:
Goa, India, 403722
Company:
Teva Pharmaceuticals
Job Id:
63852
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 RA Associate I has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of TEVA.
How you’ll spend your day
- Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients
- Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration.
- Evaluate change controls with respect to its impact on regulatory submissions, strategize filing category in accordance with the relevant guidelines and compile variation packages
- Respond to queries (from regulatory authorities or clients) concerning dossiers. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company (e.g. suppliers)
- Keep departmental database or other tracking systems up to date.
- Act as main liaison and work closely with all departments at site and across business units
- Abide by ICH guidelines and other relevant regulatory provisions, GMP requirements, occupational and environmental safety guidelines and internal SOPs
- Keep up to date with regulatory requirements and other developments in the pharmaceutical industry, including relevant legislations and guidelines (EU, US and RoW) and pharmacopoeias
- Any other duties as required/assigned by the company and/or direct superior.
Your experience and qualifications
- B.Pharm/M.Pharm
- 2-4 Yrs in handling related/ equivalent tasks- Regulatory Affairs experience with Europe & International market
Skills
- Very good command of English, speaking and writing
- Good IT skills
- Working under general supervision
- Ability to work in a team.
- Communication skills with internal and external customers.
- Organisation skills.
- Result-oriented.
- Responsible and Pro-active.
- Accuracy in practice and attention to detail.
Reports To
Associate Director, 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.
