Assistant Manager - Regulatory Affairs

Role & responsibilities

• Responsible for planning and review of new registration and re-registration dossiers for the ROW US, Europe, UK and Brazil Market.
• Evaluation of queries received from various regulatory authorities and response preparation for country submission.
• Responsible for Life cycle management and post approval activities (variation).
• Coordination with various departments and arrangement of documents and its review for dossier preparation.
• Review of documents and registration dossiers before the submissions.
• Responsible for updating and managing Regulatory related software.
• Artwork review and its management.
• Training and Monitoring on changes in regulatory guidelines and timely implement and inform to Stake holders.
• Responsible for work distribution, supervising and managing team of 2-5 members.