Navalika Polishetty

I am having 6.2 years experience in regulatory affairs.

 Prepared and submitted New DMFs, Sister filings, and CIP filings for diverse regions. 

 Managed annual reports and updates for multiple international markets. 

 Handled revisions and renewals of Certificates of Suitability to European Pharmacopoeia
(CEPs). 

 Developed regulatory strategies for Abbreviated Variation Dossier (AVD) proposals. 

 Addressed agency deficiencies and responded to DMF reviews and customer queries. 

 Prepared Applicant and Restricted parts of DMFs for specific country requirements. 

 Managed scale-up and specification revision notifications, and issued Letters of Authorization (LOAs) and Letters of Commitment (LOCs). 

 Coordinated and supported site audits by regulatory agencies and customers.

Amity University, Noida M.Pharmacy in Pharmaceutics | 2016 – 2018 | CGPA: 6.74 (1st Division)
Jawaharlal Nehru Technological University (JNTU), Hyderabad B.Pharmacy | 2012 – 2016 |
69.00% (1st Division)