Job Title: Associate III, Complex Gx, Regulatory Affairs
Date Posted: Sep 4, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job ID: 63165
Company Overview:
Teva Pharmaceuticals is committed to making good health more affordable and accessible worldwide. Operating in nearly 60 countries, Teva is the world’s leading manufacturer of generic medicines and producer of many products on the WHO Essential Medicines List. Today, over 200 million people rely on Teva medicines daily.
Opportunity Overview:
The Associate III, Complex Gx, Regulatory Affairs is responsible for independently managing the preparation and submission of high-quality regulatory filings (pre- and post-approval) for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role executes regulatory strategy, ensures FDA compliance across the product lifecycle, evaluates change controls, and determines appropriate submission pathways. In addition, the Associate III acts as a regulatory point of contact, mentors junior staff, and contributes to process improvements.
Key Responsibilities:
Regulatory Submissions & Strategy
Independently prepare, review, and compile submissions, amendments, and deficiency responses (IRs, DRLs, CRLs) using the “Right-First Time” approach.
Support early FDA engagement to align on strategy, reduce risk, and promote first-cycle approvals.
Evaluate and classify change controls; determine appropriate regulatory pathways (PAS, CBE-30, CBE-0, AR).
Compile and submit post-approval changes in compliance with FDA, ICH, and internal SOPs.
Cross-Functional Collaboration
Lead regulatory discussions with R&D, QA, and Manufacturing to resolve data issues and ensure submission readiness.
Provide strategic input and act as a regulatory contact point for cross-functional teams, including DMF holders.
Support global RA alignment efforts.
Leadership & Mentorship
Mentor and guide junior regulatory staff in strategy, compilation, and agency communications.
Conduct training and share updates on regulatory requirements and internal best practices.
Deputize for the Regulatory Manager, including approving documents, supervising activities, and reporting to leadership.
Compliance & Monitoring
Stay current with FDA and ICH guidelines; monitor FDA databases (Drugs@FDA, Orange Book).
Track and communicate regulatory changes to stakeholders.
Participate in audits, inspections, and continuous process improvement initiatives.
Experience & Qualifications:
Education:
Master’s degree in RA/QA discipline preferred.
Experience:
Minimum 7+ years in Regulatory Affairs, including 4–5 years in semi-solid, transdermal, and nasal spray complex generics.
Additional experience in Regulatory, Analytical, QA, laboratory, or production roles preferred.
Skills & Competencies:
Strong understanding of ICH and FDA guidelines.
Ability to evaluate regulatory documents and determine appropriate actions.
Excellent verbal and written communication.
Strong organizational, multi-tasking, and detail orientation.
Critical and logical thinking skills.
Internal Applicants:
Teva employees should apply via the internal career site “Employee Central” for priority consideration.
Equal Employment Opportunity:
Teva Pharmaceuticals is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, age, disability, sexual orientation, gender identity, veteran status, or any legally protected status. Accommodations during recruitment and selection are available upon request.
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