Pharmaceutical professional with broad range of work experience in RA & QAResponsible & Author for preparation of Sterility Assurance Validation package for injectable drug products [including complex injectables] for US and other market submissions for New product and for Post approval supplementsHands on Work exposure in compilation of dossier section for various complex injectables forms like Microspheres, Nano emulsions, Peptides, Iron complex, Liposome etc., in CMC sectionsProven track record of successful handling of Various Regulatory inspections including USFDA, MHRA, ANVISA, TGA, GIF, WHO etc., for various sterile dosage formsDeputed at Europe [Poland] facility for successful implementation of Quality & Regulatory compliance .
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DirectorViatris Nov 2020 - PresentIndiaRegulatory Affairs -
Associate Director Regulatory AffairsMylan Jan 2016 - Nov 2020Bengaluru, Karnataka, IndiaLeading Regulatory compliance team to handle CMC sections for General and complex generics for various injectable dosage forms.Responsible to deliver CMC documents to ensure timely submissions. SME on Authoring sections for Sterility Assurance Package of Module 3 QualityAuthoring Manufacturing controls for various injectable dosage forms of new products and for Post approval supplements.Handling of deficiency responses/Ammendments for various Health authorities.Overseeing US Annual reports and Brazil HMP renewals on CMC aspectsExposed to handle Post approval changes for US market for various supplements,Review of change request for submission impacts,Comparability protocols and QRM management for US supplements.Responsible for coordination with various SME/Sites/3rd party contract Manufacturing sites for timely dossiers compilation.Represent and involve as an auditee from Regulatory function for GMP inspections of various Health authorities. -
Head Of Quality Assurance- Strides Arcolab / AgilaStrides Jul 2005 - Dec 2015Bengaluru, Karnataka, IndiaPreviously Head of Quality Assurance for injectable facilities in Bangalore and successfully handled various Health authorities inspections including USFDA, MHRA, TGA, ANVISA etc.,Deputed in Europe [Poland] facilty, to establish quality systems. -
Junior ManagerDr. Reddy'S Laboratories May 1999 - Jul 2005Hyderabad, Telangana, IndiaLead in Microbiology department of injectable and oral dosage facilities -
OfficerAmerican Remedies May 1998 - May 1999Puducherry, IndiaWorked as microbiologist in Oral dosage forms
Frequently Asked Questions about Shankar N
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Shankar N works for Viatris
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Shankar N's current role is Director.
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