Job Title: Manager, Complex Gx, Regulatory Affairs
Date Posted: Sep 4, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job ID: 63164
Company Overview:
Teva Pharmaceuticals is on a mission to make good health more affordable and accessible, serving millions worldwide. With operations in nearly 60 countries, Teva is the world’s leading manufacturer of generic medicines and a proud producer of products listed on the World Health Organization’s Essential Medicines List. Currently, over 200 million people take Teva medicines daily.
Opportunity Overview:
The Manager, Complex Gx, Regulatory Affairs, is responsible for supervising, preparing, reviewing, and submitting high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. This role establishes regulatory strategies, manages document deliverables, ensures compliance, and oversees regulatory databases and trackers. The manager also trains regulatory staff and serves as a project team leader.
Key Responsibilities:
Regulatory Submissions:
Independently prepare, review, and compile regulatory submissions (original applications, amendments, deficiency responses, post-approval supplements) for sterile complex generic products.
Support early FDA engagement to align development strategy and reduce regulatory risk.
Ensure documents are accurate, complete, and compliant, applying a Right-First-Time approach to maximize first-cycle approvals.
Regulatory Assessment & Strategy:
Evaluate regulatory issues and provide accurate recommendations and alternatives.
Support decision-making for significant changes such as site transfers and alternate API sourcing.
Collaboration & Leadership:
Collaborate with cross-functional teams (R&D, QA, Manufacturing) to resolve regulatory challenges.
Oversee regulatory documentation systems to ensure data integrity and consistency.
Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
Other Duties:
Manage regulatory databases and trackers.
Conduct training for regulatory staff.
Perform additional projects as assigned.
Experience & Qualifications:
Education:
PharmD or BS in a scientific discipline (or equivalent).
Master’s degree in RA/QA discipline preferred.
Experience:
Minimum 8+ years in the pharmaceutical industry.
At least 5 years in Regulatory Affairs for sterile products.
2+ years experience in analytical/QC, R&D/laboratory, or production preferred.
Skills & Competencies:
Strong understanding of ICH and FDA guidelines.
Ability to evaluate regulatory documents and determine appropriate action.
Excellent verbal and written communication.
Ability to share ideas and maintain strong working relationships at all levels.
Strong organizational, multi-tasking, and attention-to-detail skills.
Critical and logical thinking skills.
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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