Teva Associate III Complex Gx Regulatory Affairs 

India, Karnataka, Bengaluru 

710121918

The Associate III, 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 semi-solid, transdermal, and nasal spray complex generic products. Working independently with minimal supervision, the Associate III will manage regulatory submissions—including original applications, amendments, deficiency responses, and postapproval supplements—while collaborating closely with cross-functional teams. This position supports regulatory strategy execution and ensures compliance with FDA requirements across the product lifecycle The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate III also serves as a regulatory point of contact for assigned products, supports junior team members through mentorship, and contributes to process improvement initiatives.

• Independently prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach.
• 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, formulation modifications, and alternate API sourcing.
• Lead regulatory discussions with R&D, quality, and manufacturing to resolve data issues and guide regulatory expectations to align on submission readiness and strategies, including global RA alignments.
• Provide strategic regulatory input and serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc.
• Monitor and manage regulatory timelines and proactively address data or document gaps.
• Independently evaluate and classify change controls for regulatory impact and determine appropriate submission pathways.
• Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements.
• Mentor and guide junior regulatory staff on compilation, regulatory strategy, and agency communications.
• Conduct training and share knowledge on updated regulatory requirements and internal best practices.
• Deputize for Regulatory Manager, including approval of documents, supervising activities, and providing updates to senior leadership.
• Track regulatory guidance updates, stay current with evolving regulatory requirements.
• Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes.
• Participate in audits, inspections, and process improvement initiatives.

• Master’s degree in RA/QA discipline, a plus.
• Minimum 7+ years of RA experience in which 4 to 5 years pharmaceutical industry experience with semi-solid, transdermal, and nasal spray complex generic products; Regulatory, Analytical, QA, laboratory or production experience 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.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

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