Job Title:
Associate II – Complex Generic Products, Regulatory Affairs
Location:
Bangalore, India – 560064
Company:
Teva Pharmaceuticals
Job ID:
63167
Posting Date:
September 12, 2025
Company Overview:
Teva Pharmaceuticals is a global leader in generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List. Teva’s mission is to make health care more affordable and accessible, positively impacting millions of lives worldwide.
Role Summary:
The Associate II, Complex Gx, Regulatory Affairs, is responsible for preparing and submitting high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. The role manages regulatory submissions, evaluates change controls, and ensures compliance with FDA and internal SOPs while collaborating with cross-functional teams. Occasionally, the Associate II will serve as a regulatory point of contact for assigned products 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.
Support early FDA engagement to align on development strategy, reduce regulatory risk, and facilitate first-cycle approvals.
Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways (e.g., PAS, CBE-30, CBE-0, AR).
Compile and submit post-approval changes ensuring compliance with FDA, ICH, and internal requirements.
Regulatory Strategy & Compliance:
Serve as regulatory contact point for cross-functional teams including R&D, QA, Manufacturing & Packaging sites, and DMF holders.
Monitor and manage regulatory timelines; proactively address data or document gaps.
Track regulatory guidance updates and stay current with evolving FDA and ICH requirements.
Monitor FDA databases (e.g., Drugs@FDA, Orange Book) and keep internal stakeholders informed of critical changes.
Quality & Process Improvement:
Participate in audits, inspections, and process improvement initiatives.
Support regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
Qualifications & Experience:
Education: Master’s degree in Regulatory Affairs (RA), Quality Assurance (QA), or a related pharmaceutical discipline preferred.
Experience: Minimum 4+ years in the pharmaceutical industry, preferably with inhalation, implant, ophthalmic, and drug-device combination products. Experience in Regulatory, Analytical, QA, laboratory, or production roles is preferred.
Skills & Competencies:
Strong understanding of ICH and FDA guidelines.
Excellent verbal and written communication skills.
Strong organizational, multitasking, and detail-oriented abilities.
Critical and logical thinking skills.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity and fostering a diverse and inclusive workplace. Accommodations are provided for candidates throughout the recruitment process as needed.
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