Teva Manager Complex Gx Regulatory Affairs 

India, Karnataka, Bengaluru 

742781688

The Manager, Complex Gx, Regulatory Affairs is responsible for the supervision, preparation, critical review, and submission of high quality regulatory submissions—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager serves as team leader for projects and is responsible for overseeing the evaluation of change controls. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The primary responsibilities of the Manager include the preparation and compilation of original applications, amendments, deficiency responses, postapproval supplements, and training of regulatory staff.

• Independently support the preparation, review, and compilation of regulatory submissions (original applications, supplements, and responses) for sterile complex generic products.

• Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Other projects and duties as required/assigned.

• Pharm D/BS in a scientific discipline or equivalent education and related experience
• Master’s degree in RA/QA discipline, preferably in Pharma.
• Minimum 8+ years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience with sterile products required, coupled with 2 years analytical/QC, R&D/laboratory or production experience is preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

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