Your Key Responsibilities

Your responsibilities include, but not limited to:

• Regulatory Team Support
• Prepare variation submissions, incl templates for artwork changes in partnership with the

Regulatory Affairs Submission Team in the required timeframe

• Support the creation, maintenance, and governance of artwork style guides across all marketed dosage forms, supporting private label, mature brands, biosimilar, prescription and OTC portfolios, ensuring compliance with HA requirements and internal initiatives such as QR codes and serialization
• Conduct 2nd review of artwork briefs and updates to ensure compliance with HA requirements and internal Artwork style guide prior to artwork creation by external agency
• Accountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments.




• Ensure key submission and post approval activity data provided by RA is up to date and accurate. Ongoing review of tracking metrics to identify areas of improvement.
• Assist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs.
• Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.
• Ensure systems and processes are in place to enable regulatory history for all applications is traceable and regulatory documents are easy to locate
• Evaluates proposed changes and provides functional input and update for affiliate regulatory actions and impact.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting.
• Liaison with international parent and license companies, third parties fo

📌 Regulatory Affairs Specialist – Labelling (India)
🏢 Sandoz India
📍 India