SAGA RA Systems and Processes Manager at Cipla

Job purpose:

To assist the SAGA RA Management Team to manage the Regulatory Systems & Processes related to New Product submissions, New Product registrations, Life Cycle Management, and overall compliance within the department by ensuring that all processes and systems are in place to facilitate high quality, timeous submissions and responses are submitted to all health authorities. 

To conduct and complete administration related to the management of these processes for all products. Gathering RA data and ensuring that systems and processes are in place for high quality data collection and statistical analysis of all RA functions across the SAGA environment. To assist with data analytics and provide and provide insights that will drive improvement in both efficiencies and effectiveness within the department. 

Accountabilities:

• Provides regulatory intelligence to Cipla SAGA RA Managers/Executives/RA Director and CEO in delivering the Cipla Pipeline for submissions and registrations. 
• Ensure pre-registration stage gate product submission and registration activities on time in full.
• Ensure Central Dossier and the life cycle management registration activities are reported regularly.
• Supports and enables delivery for the SAGA Regulatory Affairs Department. 
• Develop and manage stakeholder relationships 
• Cross functional integration support 

Full Job description available upon request

Education Qualification:

• B Pharm or Higher (Post - Graduate) Scientific degree 

Relevant work experience:

• 3 - 5 years experience in Regulatory Affairs covering all areas of the function