Regulatory Affairs Associate I – Navi Mumbai, India
Job ID: 64983 | Company: Teva Pharmaceuticals | Job Type: Full-Time | Location: Navi Mumbai, India
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making healthcare more affordable and accessible. Operating in nearly 60 countries, Teva produces many medicines listed on the World Health Organization’s Essential Medicines List, impacting over 200 million patients worldwide daily. We continuously seek passionate professionals to join our mission of improving global health.
The Opportunity
Teva is seeking a Regulatory Affairs Associate I to provide comprehensive administrative and regulatory support to the UK/IE Regulatory Affairs Team. This role ensures accurate lifecycle management of Marketing Authorisations (MAs), maintains tracking tools, regulatory systems, and documentation, while supporting new marketing applications, variations, and label updates.
Key Responsibilities
Provide administrative support to the UK/IE RA Team, including monitoring inboxes, managing documentation, and maintaining regulatory systems.
Prepare and submit straightforward variations and label updates for approved UK/IE product licenses.
Collaborate with EU Regulatory Affairs to support new Marketing Authorisation Applications and variation submissions.
Ensure electronic regulatory files are accurate, up-to-date, and compliant with Teva SOPs.
Proofread regulatory documents and mock-ups to ensure compliance with applicable standards.
Support ad hoc requests from cross-functional departments and assist with the regulatory cancellation process.
Identify opportunities to improve administrative processes and contribute to workflow efficiency.
Experience and Qualifications
Education: M. Pharma (Master of Pharmacy).
Experience: 2–4 years in regulatory affairs or a relevant pharmaceutical field, preferably with exposure to UK/IE regulatory processes.
Knowledge:
Understanding of pharmaceutical company processes and departments.
Proficiency in Microsoft Word, Excel, and Outlook.
Skills:
Excellent oral and written communication.
Strong organizational and time-management skills.
Ability to work independently and collaboratively within a team.
Analytical mindset with attention to detail.
Internal and External Relationships
Collaborate with UK/IE RA, EU RA, Manufacturing, QC, QA, Supply Chain, Medical Affairs, Marketing, and Regulatory Information Management teams.
Interact with external partners, suppliers, customers, and regulatory authorities such as MHRA and HPRA.
Reporting Structure
Reports to Associate Director, Senior Manager, or Manager, Regulatory Affairs.
Why Join Teva?
Contribute to global healthcare solutions with a company that impacts millions of lives.
Work in a dynamic, diverse, and inclusive environment with opportunities for professional growth.
Gain exposure to international regulatory affairs operations across the UK, IE, and EU markets.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities regardless of age, race, gender, religion, disability, sexual orientation, or any legally protected status. Accommodations are available for candidates during the recruitment process.
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