Teva Pharma hiring Regulatory Associate II in Bangalore. Apply now for US FDA submissions role in ophthalmic, inhalation, and combination products.
Teva Pharmaceuticals, a global leader in generic and specialty medicines, is inviting applications for the role of Regulatory Associate II – US (Ophthalmic/Inhalation) at its Bangalore, India location. This opportunity is ideal for experienced professionals in Regulatory Affairs (RA) with a focus on ophthalmic, inhalation, implant, and drug-device combination products. Regulatory Associate Job at Teva
If you have expertise in US regulatory submissions, FDA compliance, and lifecycle management, this is your chance to grow your career with one of the world’s most recognized pharmaceutical companies.
About Teva Pharmaceuticals
Teva Pharmaceuticals is a multinational pharmaceutical company headquartered in Israel, with operations spanning over 60 countries. Known for its leadership in generic drugs and a growing specialty medicines portfolio, Teva delivers high-quality, affordable treatments that impact millions of patients worldwide. Regulatory Associate Job at Teva
In India, Teva operates significant research, development, and regulatory functions, providing professionals with opportunities to contribute to global submissions and gain regulatory exposure to the US market.
Job Overview
| Details | Information |
|---|---|
| Company | Teva Pharmaceuticals |
| Position | Regulatory Associate II – US (Ophthalmic/Inhalation) |
| Location | Bangalore, Karnataka, India |
| Experience Required | 4–6+ years in Regulatory Affairs (US market) |
| Education | B.Pharm, M.Pharm, or MSc |
| Specialization | Ophthalmic, Inhalation, Implant, Drug-Device Combination |
| Employment Type | Full-time |
| Regulatory Scope | Pre-approval and post-approval US FDA submissions |
| Application Mode | Email (Apeksha.Shinde01@teva.co.in) |
Job Description
The Regulatory Associate II will play a key role in preparing, reviewing, and managing regulatory submissions for the US pharmaceutical market. The role involves handling pre-approval and post-approval activities, ensuring compliance with FDA regulatory guidelines, and supporting drug-device combination products. Regulatory Associate Job at Teva
This role requires strong expertise in ophthalmic, inhalation, implant, and drug-device combination submissions, along with hands-on experience in FDA submission pathways (PAS, CBE-0, CBE-30).
Key Responsibilities
- Manage regulatory submissions for pre-approval and post-approval stages of products in the US market.
- Prepare, compile, and review regulatory dossiers for ophthalmic, inhalation, implant, and combination products.
- Ensure strict compliance with US FDA regulations and submission requirements.
- Handle regulatory submission pathways including Prior Approval Supplement (PAS), CBE-0, and CBE-30.
- Collaborate with cross-functional teams such as Quality Assurance, R&D, Clinical, and CMC for submission readiness.
- Support regulatory strategy for lifecycle management of assigned products.
- Track regulatory changes and adapt submission strategy in compliance with evolving guidelines.
- Regulatory Associate Job at Teva
Qualifications and Skills Required
- Education: B.Pharm, M.Pharm, or MSc.
- Total Experience: Minimum 6+ years in the pharmaceutical industry, including at least 4+ years in Regulatory Affairs (US submissions).
- Strong expertise in ophthalmic, inhalation, implant, and drug-device combination products.
- Hands-on experience in FDA submission pathways: PAS, CBE-0, and CBE-30.
- Excellent understanding of US FDA regulatory guidelines and submission formats.
- Strong documentation, review, and analytical skills.
- Ability to collaborate effectively with cross-functional teams and external stakeholders.
- Effective verbal and written communication skills.
Regulatory Associate Job at Teva
Note: Applications with less than 3 years of relevant Regulatory Affairs experience will not be considered.
Why Join Teva Pharmaceuticals?
- Work with a leading global pharmaceutical company trusted worldwide.
- Contribute to the development and approval of innovative drug-device combination products.
- Gain exposure to US market regulatory strategies and submissions.
- Competitive compensation with structured career growth opportunities.
- Opportunity to collaborate with a global team of experts across regulatory, clinical, and development functions.
- Regulatory Associate Job at Teva
Application Process
Interested candidates who meet the eligibility criteria are encouraged to apply by sending their updated resume to the official hiring contact. Regulatory Associate Job at Teva
Send your CV to:
📧 Apeksha.Shinde01@teva.co.in
Ensure that your email subject line clearly mentions “Application for Regulatory Associate II – US (Ophthalmic/Inhalation)”. Regulatory Associate Job at Teva
Frequently Asked Questions (FAQs)
Q1. What is the educational qualification required for the Regulatory Associate role at Teva?
A: Candidates must hold a B.Pharm, M.Pharm, or MSc degree in pharmaceutical sciences or a related field.
Q2. How much experience is required?
A: Applicants must have at least 6 years of total pharmaceutical experience, with a minimum of 4 years in Regulatory Affairs (US submissions).
Q3. Which product areas will this role focus on?
A: The role focuses on ophthalmic, inhalation, implant, and drug-device combination products.
Q4. What submission pathways are expected?
A: Candidates must be familiar with PAS, CBE-0, and CBE-30 FDA pathways.
Q5. Where is the position located?
A: The position is based in Bangalore, Karnataka, India.
Q6. What is the mode of application?
A: Applications must be submitted via email to Apeksha.Shinde01@teva.co.in.
Conclusion
The Regulatory Associate II role at Teva Pharmaceuticals in Bangalore offers an excellent opportunity for experienced Regulatory Affairs professionals to advance their careers in the US pharmaceutical market. By contributing to ophthalmic, inhalation, and combination product submissions, you will play a critical role in ensuring compliance with FDA guidelines and bringing essential therapies to patients. Regulatory Associate Job at Teva
If you have the required qualifications and expertise, apply today and join a global leader in pharmaceuticals.
