job title: Regulatory affairs associate 2(teva)

Roles and Responsibilities

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.