Regulatory Affairs Manager

• RA Profile (EU Market Filing and Query & Response)

• Department:

  Regulatory Affairs

• Reporting to:

  Senior Director Global Regulatory Affairs

• Job Location:

  Bangalore

• Industry:

  Pharmaceuticals

Key Responsibilities

• Regulatory submissions to the EU Market and Query Response subsequently comply with applicable regulatory requirements
• Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant departments and prepare submissions.
• Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalise the documents, coordinate and prepare submissions
• Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments. Draft and review Product Information & labelling as required.
• Prepare a version-controlled CMC write-up for the respective section.
• Track Variation filings and approvals. Maintain the database.
• Perform registration compliance reviews against quality documentation.

Skills & Knowledge Required

• CMC Documents Review
• Previous Experience with EU Markets Filing and Query & Response
• Experience with Lorenz DocuBridge or other eCTD software desired
• Self-motivated, detail-oriented, and highly organised
• Ability to collaborate and interact effectively with a variety of personnel
• Excellent computer skills
• Effective communication skills (written and verbal)
• Proficiency in speaking, comprehending, reading, and writing English is required.