Job Title: Associate II, Complex Gx, Regulatory Affairs
Date Posted: Sep 4, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job ID: 63166
Company Overview:
Teva Pharmaceuticals is dedicated to making good health more affordable and accessible, serving millions worldwide. Operating in nearly 60 countries, Teva is the world’s leading manufacturer of generic medicines and a producer of many products on the WHO Essential Medicines List. Currently, over 200 million people take Teva medicines daily.
Opportunity Overview:
The Associate II, Complex Gx, Regulatory Affairs, is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The role involves managing regulatory submissions, evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), and ensuring compliance with FDA guidelines and internal SOPs. The Associate II may also serve as a regulatory point of contact and contribute to process improvement initiatives.
Key Responsibilities:
Regulatory Submissions:
Prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using a "Right-First-Time" approach.
Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) in accordance with FDA, ICH, and internal requirements.
Support early FDA engagement to align on development strategy and reduce regulatory risk.
Regulatory Assessment & Decision-Making:
Support evaluations for significant changes including site transfers and alternate API sourcing.
Evaluate and classify change controls for regulatory impact and determine submission pathways.
Collaboration & Communication:
Serve occasionally as a regulatory contact for cross-functional teams (R&D, QA, Manufacturing & Packaging, DMF holders).
Track regulatory guidance updates and monitor FDA databases (e.g., Drugs@FDA, Orange Book).
Process Improvement & Compliance:
Participate in audits, inspections, and continuous improvement initiatives.
Monitor regulatory timelines and proactively address data or document gaps.
Experience & Qualifications:
Education:
Master’s degree in RA/QA discipline, preferably in Pharma.
Experience:
Minimum 4+ years in the pharmaceutical industry with sterile products.
Regulatory, Analytical, QA, laboratory, or production experience preferred.
Skills & Competencies:
Understanding of ICH and FDA guidelines.
Excellent verbal and written communication.
Strong organizational, multi-tasking, and attention-to-detail skills.
Critical and logical thinking.
Internal Applicants:
Current Teva employees should apply via the internal career site "Employee Central" for priority consideration.
Equal Employment Opportunity:
Teva Pharmaceuticals is committed to equal opportunity employment. Accommodations are provided during recruitment and selection upon request.
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