• Preparation, Submission of DMFs (Open and Closed parts) as per country specific requirements.
• Follow up with cross functional departments for input data for DMF compilation
• Preparation of action plan, coordination with specific departments for related activities.
• Follow up with concerned departments for deficiency responses.
• Updation of DMFs (Open Part of DMF) for all customers.
• Assessment of changes proposed by cross functional department on regulatory classifications & regulatory risks.
• Preparation of documentation for EU Written Confirmation (WC).
• Postgraduate in Chemistry / M. Pharmacy having knowledge on regulatory registration process and regulatory guidelines of various countries.
• Proficient in regulatory requirements for the API industry
• Knowledge of documentation related to quality and regulatory guidelines.
• 6-9 years of experience in Pharmaceutical industry and API Regulatory Affairs.