Job Description
Join Sun Pharma as a Regulatory Affairs Associate, focusing on FDA and Health Canada drug submissions. This hybrid role combines scientific and regulatory responsibilities.
In this role, you will prepare and file submissions for various dosage forms, ensuring compliance with strict guidelines. Your expertise will help manage product labeling and respond to requests from regulatory bodies. The job invites a proactive approach to maintaining regulatory standards and improving patient access to essential medications.
Key Responsibilities:
• File eCTD submissions for drug products
• Review internal documents for regulatory compliance
• Respond effectively to regulatory agencies’ inquiries
• Maintain product monographs and annual reports
• Stay informed on current regulatory guidelines
Requirements:
• Minimum B.Sc. in relevant scientific discipline
• 3-5 years of regulatory affairs experience
• Knowledge ...
In this role, you will prepare and file submissions for various dosage forms, ensuring compliance with strict guidelines. Your expertise will help manage product labeling and respond to requests from regulatory bodies. The job invites a proactive approach to maintaining regulatory standards and improving patient access to essential medications.
Key Responsibilities:
• File eCTD submissions for drug products
• Review internal documents for regulatory compliance
• Respond effectively to regulatory agencies’ inquiries
• Maintain product monographs and annual reports
• Stay informed on current regulatory guidelines
Requirements:
• Minimum B.Sc. in relevant scientific discipline
• 3-5 years of regulatory affairs experience
• Knowledge ...