Sunil Patil

Regulatory Affairs Associate @Target Healthcare

Mumbai, IN

Oversee and perform the necessary activities in order to maintain Client’s site licences2. Communicate with internal and external stakeholders on the status and requirements of all regulatory submissions, providing guidance on the documentation required in support of applications.3. Collate and review documentation in support of the Company’s Marketing Authorisations prior to submission, ensuring supporting documents are ’right first time’ and manage priorities to meet business objectives.4. Co-ordinate with the regulatory partners of customers to ensure Marketing Authorisation compliance. Manage life cycle/ post authorization changes for UK relating to CMC, Clinical, Safety and product information changes.5. Inform the Head of Quality of any problems that could impact on the approval or maintenance of licence requirements (site and product) licences.6. Identify and manage regulatory projects, setting up project plans to ensure that regulatory approvals are delivered and can be implemented on time.Develop and maintain a detailed plan of all known regulatory activities for the company licences.7. Process all Marketing Authorisations and variation applications in a timely manner and ensure that all responses to regulatory questions are undertaken in line with defined targets.

University of Mumbai

Master of Pharmacy

Savitribai Phule Pune University

B.Pharm