Associate II – Complex Generics, Regulatory Affairs
Location: Bangalore, Karnataka, India (560064)
Company: Teva Pharmaceuticals
Job ID: 63167
Employment Type: Full-time
Posted On: January 9, 2026
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, dedicated to improving access to high-quality, affordable healthcare worldwide. Operating across nearly 60 countries, Teva supports over 200 million patients every day and maintains one of the industry’s most extensive portfolios of medicines listed on the World Health Organization’s Essential Medicines List. Teva’s regulatory teams play a critical role in advancing complex generics and ensuring global compliance across evolving regulatory landscapes.
Role Overview
Teva is seeking an Associate II – Complex Generics, Regulatory Affairs to support regulatory activities for U.S. FDA-regulated complex generic products, including inhalation, implant, ophthalmic, and drug-device combination products. This role involves preparing and submitting high-quality regulatory filings across the product lifecycle, from pre-approval submissions to post-approval changes.
Working with moderate to minimal supervision, the Associate II will manage regulatory submissions, assess change controls, determine appropriate regulatory pathways, and collaborate closely with cross-functional stakeholders to ensure compliance with FDA, ICH, and internal regulatory standards.
Key Responsibilities
Prepare, review, and compile original applications, amendments, deficiency responses (IRs, DRLs, CRLs), and supplements using a Right-First-Time submission approach
Support early FDA engagement activities to align development and regulatory strategies and reduce approval risk
Assess regulatory impact of significant post-approval changes such as site transfers, formulation changes, and alternate API sourcing
Evaluate and classify change controls and determine appropriate regulatory pathways (PAS, CBE-30, CBE-0, Annual Report)
Compile and submit post-approval regulatory submissions in compliance with FDA and ICH guidelines
Act as a regulatory liaison for cross-functional teams including R&D, Quality, Manufacturing, Packaging, and DMF holders
Monitor and manage regulatory timelines, proactively identifying data gaps and submission risks
Track updates to FDA guidance documents and regulatory policies impacting complex generics
Monitor FDA databases such as Drugs@FDA and the Orange Book and communicate relevant updates to stakeholders
Participate in audits, inspections, and continuous process improvement initiatives
Experience Required
Minimum 4+ years of pharmaceutical industry experience
Hands-on experience with complex generic products, including inhalation, implant, ophthalmic, or drug-device combination products
Prior exposure to U.S. FDA regulatory submissions, post-approval changes, and lifecycle management activities
Experience in Regulatory Affairs is required; background in Analytical, Quality Assurance, Laboratory, or Manufacturing functions is an advantage
Educational Qualifications
Master’s degree in Regulatory Affairs or Quality Assurance, preferably within the pharmaceutical domain
Required Skills & Competencies
Strong understanding of FDA and ICH regulatory guidelines
Excellent written and verbal communication skills
Strong organizational and multitasking abilities with high attention to detail
Demonstrated critical thinking, problem-solving, and regulatory decision-making skills
Ability to work effectively in cross-functional and matrix-based global teams
Why Join Teva
At Teva, regulatory professionals contribute directly to advancing complex generics and innovative delivery systems that improve patient access to essential therapies. This role offers exposure to cutting-edge regulatory challenges, collaboration with global teams, and long-term career growth in regulatory leadership.
Equal Employment Opportunity
Teva Pharmaceuticals is an equal opportunity employer committed to building a diverse and inclusive workplace. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, gender identity, or any other legally protected status. Reasonable accommodations are available throughout the recruitment process.
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