Aparna Parinam

Group Head - Regulatory Cmc, Global Drug Development @Novartis

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

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WORK HISTORY

Feb 2020 — Present

Group Head - Regulatory Cmc, Global Drug Development @Novartis

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Hyderabad, IN

EDUCATION

1980 — 1990

Perpetual Succour Convent HIgh School

Std 1-10

1990 — 1996

Goa University

M Pharm, Pharmacy

N/A

Fairleigh Dickinson University

MS, Pharmaceutical Chemistry

SKILLS

PharmaceuticsAndaElectronic Common Technical Document (Ectd)ValidationGlpGeneric ProgrammingTeam LeadershipRegulatory AffairsPharmaceutical IndustrySopFdaCmc Regulatory AffairsEctdRegulatory RequirementsGood Laboratory Practice (Glp)FormulationU.s. Food and Drug Administration (Fda)Regulatory SubmissionsTechnology TransferGmpLc-MsAbbreviated New Drug Application (Anda)Biotechnology

ABOUT APARNA PARINAM

A highly experienced Regulatory Affairs professional having experience in submissions in the US, Canadian, EU, Japan and ASEAN markets.A Pharmaceutical Chemistry and Quality Assurance graduate with strong communication and analytical skills. Possess 20 years of industry experience in areas including formulation development and international regulatory affairs. Passionate and mindful leader who believes in leveraging the strength of people and teams- Led a large team of professionals responsible for life cycle maintenance- Conceptualized and set up of the Site RA team at Teva (formerly ratiopharm) Goa, initiating regulatory submissions to Europe, Canada and International markets- Responsible for building and set up of a large team (+100) of RA professionals, and executing it from a green field project - Managed a Site RA team responsible for submissions and query responses to regulatory agencies of various countries- Provide strategic regulatory input to team members for post-approval changes requiring regulatory submissions.

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Aparna Parinam — Group Head - Regulatory Cmc, Global Drug Development at Novartis in Hyderabad, TG, IN | Unifers