Regulatory Affairs Associate II

Date: Oct 1, 2025

Location:

Bangalore, India, 560064

Company: Teva Pharmaceuticals

Job Id: 62833

Who we are

Together, 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 opportunity

Teva is seeking a detail-oriented and proactive Regulatory Affairs Labeling Associate to support Canadian regulatory labeling activities. This role is responsible for monitoring Health Canada safety updates, managing product monograph (PM) creation and updates, coordinating bilingual labeling components, and ensuring regulatory compliance across multiple systems and stakeholders.The candidate must demonstrate the ability to work with minimal supervision and possess a thorough understanding of Health Canada labeling regulations, applying this knowledge effectively across all work output.

How you’ll spend your day

Monthly review of Health Canada brand safety updates.
Align updates with internal product lists and communicate relevant changes to cross-functional teams.
Strategize and implement changes impacting multiple product documents.
Track and retrieve the latest innovator PMs from the Health Canada Drug Product Database.
Create and update Teva PMs by referencing Canadian innovator products.
Use tools like TVT for document comparison, ensuring compliance with HC master templates.
Perform thorough QC, editing, formatting, and coordinating the review and approval processes.
Collaborate with French translators for bilingual PMs.
Coordinate with artwork team the creation of packaging components (Inserts/Outserts/Cartons/Labels) for sANDS submissions.
Manage the Veeva Artwork Process to obtain final artworks.
Conduct quality reviews of labeling and submission documents using manual proofreading and electronic tools (TVT).
Support other safety Level III updates and regulatory commitments in collaboration with the Canada RA team.
Address Health Canada queries including clarifaxes, screening acceptance, pause-the-clock requests, extensions, BA/BE queries, and withdrawals.
Maintain accurate project trackers to monitor due dates, priorities, and timelines for all assigned projects.
Keep databases updated and share current PMs and relevant details with internal and external stakeholders.
Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.
Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations and publishing software.
Stay current with Health Canada regulations, guidelines, and SOPs.
Work effectively in a team environment with minimal supervision.
Perform additional job-related duties as required by management and evolving processes.

Your experience and qualifications

Pharma Graduate / Post Graduate with a Scientific or Regulatory background or equivalent combination of education and experience
3+ years of experience in Regulatory Affairs with a focus on Canadian labeling.
Knowledge of Health Canada regulatory requirements related to Canadian labeling
Knowledge of XML/SPM development and Health Canada requirements.

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: Internal Career Site

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 Commitment

Teva 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.