Teva Pharmaceuticals is hiring for the position of Regulatory Affairs Specialist II in Bangalore, India. The role focuses on regulatory submissions, product lifecycle management, health authority interactions, and regulatory compliance for branded, specialty, and generic products across International Markets (IM).
Candidates with a B.Pharm or M.Pharm qualification and at least one year of experience in regulatory affairs or a related R&D area focused on compliance activities can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Teva Pharmaceuticals |
| Job Role | Regulatory Affairs Specialist II |
| Job ID | 71029 |
| Location | Bangalore, India |
| Qualification | B.Pharm / M.Pharm (preferred) |
| Experience | 1 year |
| Department | Regulatory Affairs |
| Product Portfolio | Branded, Specialty and Generic Products |
| Work Region | International Markets (IM) |
Position
Regulatory Affairs Specialist II
The selected candidate will manage and support regulatory registration activities throughout the product lifecycle, ensuring compliance with local regulations and GxP requirements across International Markets.
Key Responsibilities
- Manage lifecycle activities for branded, specialty, and generic products, including variations, renewals, and responses to health authority queries.
- Support regulatory labeling activities in collaboration with assigned market regulatory teams.
- Monitor change control activities involving sites, suppliers, and global regulatory affairs work processes.
- Ensure marketed products comply with applicable local regulations.
- Maintain regulatory systems and documentation in accordance with compliance requirements.
- Work with regulatory teams across International Markets to complete assigned activities.
- Ensure required training is completed and documented before performing GxP activities.
- Use regulatory systems such as GRIDS, GI Insights, Teva Art, and Veeva.
- Support assigned artificial intelligence (AI) initiatives.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Educational Qualification: B.Pharm or M.Pharm, preferred.
- Experience: One year of experience in regulatory affairs or a related R&D area, focusing on compliance activities.
- Knowledge or experience relevant to regulatory submissions, product lifecycle management, and compliance activities is aligned with the responsibilities of this role.
Required Skills
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Understanding of regulatory compliance activities.
- Ability to coordinate with regulatory affairs teams across International Markets.
- Familiarity with regulatory documentation and systems relevant to the role.
