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Regulatory Affairs Associate II

Regulatory Affairs Associate II

Watson Pharama

3 - 8 years

5 - 10 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

regulatory affairs associate sap publishing french pharma xml packaging associate ii monitoring recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Watson Pharama

Pharmaceuticals

Pharma City

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Regulatory Affairs Associate II