Harshavardhan Reddy

Regulatory Affairs Officer @Makrocare

Hyderabad, TG, IN
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Mar 2016 — Present

Regulatory Affairs Officer @Makrocare

View department →

Hyderabad, IN

1) Compilation of Dossiers to Regulatory and Semi regulatory markets(Covering Middle East,LATAM and ASEAN region).2) Providing Expedite response to RTQ(Response to question) raised by helath authority.3) Co ordinating with various cross functional departments to gain the data for submission.4) Review of documents received from Manufacturing site.5) Managing post approvals like International Renewals (compiled approximately 150 dossiers for various regions).6) Knowledge on compilation of CTD,ACTD dossiers.

EDUCATION

2010 — 2012

Jawaharlal Nehru Technological University

Master of pharmacy

2006 — 2010

Srikirshna chaitanya college of pharmacy

Bachelor of Pharmacy (B.Pharm.)

SKILLS

SopRegulatory ComplianceRegulatory AffairsClinical TrialsRegulatory FilingsEctdGlobal Regulatory ComplianceStandard Operating Procedure (Sop)Microsoft OfficeMicrosoft ExcelPowerpointMicrosoft WordAndaPublic SpeakingRegulatory SubmissionsGmp

ABOUT HARSHAVARDHAN REDDY

Being a dedicated and focused individual, I am determined to add value to the organisation I work for, through my experience knowledge and learning ability.My prime goal is to understand professional environment and capitalize on opportunities.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Harshavardhan Reddy — Regulatory Affairs Officer at Makrocare in Hyderabad, TG, IN | Unifers