Job Title:
Manager, Complex Gx, Regulatory Affairs
Date Posted:
4 Sept 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job ID:
63164
Company Overview:
Teva Pharmaceuticals is a global leader in generic medicines and a producer of many products on the WHO Essential Medicines List. Teva’s mission is to make healthcare more affordable and accessible, positively impacting millions of people worldwide. Operating in nearly 60 countries, Teva values diversity, inclusion, and innovation in advancing global health.
Role Overview:
The Manager, Complex Gx, Regulatory Affairs, supervises and manages high-quality regulatory submissions—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The role involves evaluating complex regulatory issues, providing recommendations, establishing regulatory strategies, managing document deliverables, and training regulatory staff. The manager also oversees regulatory databases and trackers to ensure accurate updates.
Key Responsibilities:
Independently prepare, review, and compile regulatory submissions (original applications, supplements, and responses) for sterile complex generic products.
Support early FDA engagement to align development strategy, reduce regulatory risk, and maximize first-cycle approvals.
Evaluate regulatory assessments for significant changes, including site transfers and alternate API sourcing.
Ensure submission documents are accurate, complete, and compliant with FDA regulations (Right-First-Time approach).
Collaborate with cross-functional teams (R&D, QA, Manufacturing) to resolve regulatory challenges.
Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
Manage other projects and duties as required/assigned.
Experience and Qualifications:
Education: Pharm D / B.Sc. in a scientific discipline or equivalent; Master’s degree in RA/QA preferred.
Experience: Minimum 8+ years in the pharmaceutical industry, including:
5+ years in Regulatory Affairs with sterile products
2 years in analytical/QC, R&D/laboratory, or production experience preferred
Strong understanding of ICH and FDA guidelines.
Ability to evaluate regulatory documents and determine appropriate actions.
Excellent verbal and written communication skills.
Ability to establish and maintain good working relationships internally and externally.
Strong organizational skills, detail-oriented, and able to multi-task.
Critical and logical thinking skills.
Internal Applicants:
Current Teva employees should apply via the internal career site on “Employee Central” for priority consideration and access to internal-only opportunities.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity. Employment decisions are based on merit, qualifications, and business requirements without regard to age, race, creed, color, religion, sex, disability, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided to support candidates during the recruitment process.
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