Associate II, Complex Gx, Regulatory Affairs

Bangalore, Karnataka
Permanent
Full-time

28 days ago

Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe Associate II, 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 sterile complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions-including original applications, amendments, deficiency responses, and postapproval supplements-while collaborating closely with cross-functional teams. The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives.How you'll spend your day

With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach.
Work with their manager to 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.
On occasion, 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.
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.
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.

Your experience and qualifications

Master's degree in RA/QA discipline, preferably in Pharma.
Minimum 4+ years pharmaceutical industry experience with sterile products; Regulatory, Analytical, QA, laboratory or production experience preferred.
Demonstrates an understanding of ICH and FDA guidelines
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.

Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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