Regulatory Affairs Associate

Job Description

Responsible for regulatory activities for product registrations, lifecycle management, compliance, and maintenance of marketing authorizations across European Union (EU), United Kingdom (UK), Australia, and New Zealand markets. Ensure timely preparation, submission, approval, and maintenance of regulatory dossiers in compliance with regional regulatory requirements.

Key Responsibilities:

1. Regulatory Submissions (Prepare, compile and submit regulatory dossiers for: New Marketing Authorization Applications (MAAs), Variations/Post-approval Changes, Renewals, Line Extensions and Artwork/Labeling Updates and responses to health authorities queries) for advanced markets including EU/UK/ANZ/Israel.

2. Lifecycle Management: Maintain product registrations throughout the product lifecycle, track regulatory commitments, approvals, renewals, and variations.

3. Provide regulatory impact assessments for change controls initiated from manufacturing, packaging, labelling functions.

4. Dossier Management: Prepare and maintain CTD/eCTD dossiers, compile and review Module 1 administrative documents for regional compliance and coordinate updates to Modules 2-5 with cross-functional teams.

5. Regulatory Intelligence & Compliance: Monitor changes in EU, UK, TGA, and Medsafe regulations. Evaluate the regulatory impacts and provide recommendations to internal stakeholders.

6. Support communication with regulatory agencies, local affiliates and coordinate with business partners.

7. Labeling & Artwork Review: review prescribing information, SmPC, PIL, carton and label texts. Ensure compliance with regional labeling requirements. Support implementation of safety updates and labeling variations.

8. Cross-Functional Collaboration: Work closely with cross functional teams, maintain regulatory tracking tools and databases. Generate reports for submission status, approvals, commitments, and regulatory metrics.

9. Managing financial activities like timely payment of Health authority invoices, consultant & customer invoices