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)