Are you an experienced Regulatory Affairs professional seeking to make an impact in the US pharmaceutical market?
Teva Pharmaceuticals is looking for a Regulatory Associate II in Bangalore, India, with expertise in ophthalmic, inhalation, implant, and drug-device combination products.
This role offers the opportunity to work on both pre-approval and post-approval regulatory submissions, ensuring compliance with evolving FDA guidelines.
๐ Key Responsibilities
- Manage Regulatory Affairs for pre-approval and post-approval submissions in the US market.
- Prepare and review regulatory dossiers for ophthalmic, inhalation, implant, and drug-device combination products.
- Ensure compliance with FDA regulations and submission pathways including PAS, CBE-0, CBE-30.
- Collaborate with cross-functional teams (QA, R&D, Clinical, CMC) for regulatory documentation.
- Support regulatory strategy for lifecycle management of assigned products.
๐ Qualifications & Skills Required
- Total Experience: 6+ years, with 4+ years in Regulatory Affairs (US submissions).
- Strong background in inhalation, ophthalmic, implant, and combination products.
- Hands-on experience with FDA submission pathways: PAS, CBE-0, CBE-30.
- Excellent understanding of US regulatory guidelines.
- Strong documentation, communication, and cross-functional collaboration skills.
๐ Note: Applications with less than 3 years of relevant Regulatory Affairs experience will not be considered.
๐ก Why Join Teva?
- Work with a leading global pharmaceutical company.
- Opportunity to contribute to innovative drug-device combination products.
- Exposure to US market regulatory strategy and approvals.
- Competitive compensation and career growth opportunities.
๐ฉ How to Apply
Interested candidates can send their updated CV to:
๐ง Apeksha.Shinde01@teva.co.in