Are you passionate about regulatory affairs and eager to contribute to affordable healthcare? Teva Pharmaceuticals, a global leader in generic medicines, is hiring an Associate II, Complex Gx, Regulatory Affairs in Bangalore, India. This role offers a unique opportunity to work on high-quality regulatory filings for U.S. FDA-regulated complex generic products, including inhalation, implant, ophthalmic, and drug-device combinations. Join a mission-driven team impacting 200 million lives daily and advance your career with a company listed on the World Health Organization’s Essential Medicines List.
Responsibilities of Associate II, Regulatory Affairs
As an Associate II, you’ll play a pivotal role in ensuring compliance with U.S. FDA regulations and internal SOPs while collaborating with cross-functional teams. Your day-to-day responsibilities include:
- Preparing, reviewing, and compiling regulatory submissions (new applications, amendments, deficiency responses, and post-approval supplements) using a “Right-First Time” approach.
- Supporting early FDA engagement to align development strategies and secure first-cycle approvals.
- Evaluating change controls and determining regulatory pathways (PAS, CBE-30, CBE-0, AR) for site transfers, formulation changes, and API sourcing.
- Acting as a regulatory point of contact for R&D, QA, manufacturing, and DMF holders.
- Monitoring regulatory timelines and proactively addressing data or document gaps.
- Compiling and submitting post-approval changes in compliance with FDA, ICH, and internal guidelines.
- Tracking updates in FDA databases (e.g., Drugs@FDA, Orange Book) and informing stakeholders of critical changes.
- Participating in audits, inspections, and process improvement initiatives.
Qualifications and Skills
Teva seeks a detail-oriented professional with strong regulatory expertise. The ideal candidate should have:
- Education: Master’s degree in Regulatory Affairs (RA) or Quality Assurance (QA), preferably in pharmaceuticals.
- Experience: Minimum 4+ years in the pharmaceutical industry, with expertise in inhalation, implant, ophthalmic, or drug-device combination products. Experience in regulatory affairs, analytical, QA, laboratory, or production is preferred.
- Technical Knowledge: Understanding of ICH and FDA guidelines for complex generics.
- Skills: Excellent verbal and written communication, strong organization, multitasking, critical thinking, and attention to detail.
- Location: Must be based in or willing to relocate to Bangalore, India (560064).
Why Join Teva Pharmaceuticals?
Teva Pharmaceuticals is committed to making good health affordable and accessible. As an Associate II, you’ll:
- Work with a global leader in generic medicines, impacting millions worldwide.
- Collaborate with diverse teams across 60 countries, fostering professional growth.
- Contribute to innovative regulatory strategies for complex generic products.
- Benefit from Teva’s equal opportunity commitment, ensuring a diverse and inclusive workplace.
- Participate in a mission aligned with the World Health Organization’s Essential Medicines List.
