Associate II, Complex Gx, Regulatory Affairs at Teva Pharmaceuticals

Teva Pharmaceuticals, a global leader in generic medicines and a top player in sterile product development, is hiring for the role of Associate II, Complex Gx, Regulatory Affairs in Bangalore, India.

This is an excellent opportunity for experienced regulatory professionals with strong expertise in US FDA submissions, ICH guidelines, sterile formulations, and post-approval compliance. If you’re passionate about advancing affordable healthcare and making a global impact, this role is tailored for you.

Key Responsibilities

As an Associate II, Regulatory Affairs, your day-to-day responsibilities will include:

• Preparing, reviewing, and compiling regulatory submissions, deficiency responses (IRs, DRLs, CRLs), and amendments.
• Supporting early FDA engagement to align on development strategies and reduce regulatory risk.
• Conducting regulatory assessments for significant changes (site transfers, alternate API sourcing).
• Serving as a regulatory contact for cross-functional teams including R&D, QA, Manufacturing, and DMF holders.
• Monitoring regulatory timelines and proactively addressing document gaps.
• Evaluating change controls and determining submission pathways (PAS, CBE-30, CBE-0, AR).
• Submitting post-approval changes in compliance with FDA, ICH, and internal requirements.
• Tracking regulatory guidance updates and monitoring FDA databases (Orange Book, Drugs@FDA).
• Participating in audits, inspections, and process improvement initiatives.

Required Qualifications

To succeed in this role, candidates should have:

• Master’s degree in Regulatory Affairs, Quality Assurance, or Pharmacy.
• Minimum 4+ years’ pharmaceutical industry experience (sterile products preferred).
• Strong knowledge of FDA and ICH regulatory guidelines.
• Experience with sterile product development, analytical/QA, or production.
• Excellent communication and organizational skills.
• Strong critical and logical thinking abilities.

Benefits of Working with Teva

• Opportunity to work with the world’s leading generic medicines manufacturer.
• Exposure to complex generic product development and regulatory strategy.
• Collaborative global work environment with career growth opportunities.
• Inclusive workplace culture with equal employment opportunity commitment.

How to Apply

Application Link