Job Requirements: 

• Academic Qualification: Advanced Degree in a life sciences or healthcare related fields 

• Relevant Experience: 10+ years of proven working experience in regulations and guidelines. 

• Strong interpersonal skills 

• Strong communication, presentation and negotiation skills, problem - solving.  

• Proficiency in data analysis. 

Job Responsibilities: 

• Overseeing the regulatory strategy and compliance for both research and manufacturing activities.  

• Provide strategic direction for the regulatory affairs department to ensure compliance with national and international regulations. 

• Overseen the preparations and submission of regulatory filings including new product applications and post – market submission.  

• Collaborate with the Quality Assurance to integrate regulatory requirements into quality systems. Coordinate and provide strategic inputs to cross - functional teams to facilitate regulatory compliance throughout the process.  

• Establish and maintain relationship with Central and State regulatory agencies like CDSCO, DCGI Karnataka, Food Safety Standard Authority of India (Central and State), Central Bureau of Narcotics, DGFT, Department of Labor, Department of Factories and Boilers, GST Council etc and rep resent the organisation in regulatory interactions and inspections.  

• Maintain compliance with all relevant regulatory requirements and industry standards.  

• Stay informed about the changes in regulatory requirements and advise the organisation Interact with the clients to understand their regulatory requirements and expectations.  

• Lead and mentor a team of regulatory professionals, fostering a culture of excellence and continuous improvement.  

• Drive continuous improvement initiatives within the regulatory affairs functions, optimising processes and enhancing efficiency.