Sheetal Sarinmai

Team Lead-Regulatory Affairs at Freyr Solutions

Role
Senior Regulatory Affairs Associate at Freyr Solutions
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers

About Sheetal Sarinmai

Managing all aspects of the assigned projects/products, viz. preparation, review and submission of the marketing authorization applications for Medicinal products.• Timely and satisfactory response during the entire procedures(DCP, MRP), variations/amendments, renewals, etc.•Interacting with clients/customers to discuss and provide strategy/solutions to regulatory issues and/or problems and also coordinate for primary data documents, certificates & samples required for submission.•Preparation and execution of Training calendar, program and material for Trainee/Associate Regulatory Affairs.•Assisting Asst. Manager, Regulatory Affairs with preparation of Training calendar, reporting the status of regulatory affairs activities and project status reports. •Maintain a working knowledge of regulatory requirements and guidelines and sharing regulatory updates with the team members.

Experience

  1. Senior Regulatory Affairs Associate

    Freyr Solutions

    Jan 2013 — Present · Hyderabad, IN

    Expertise in Dossier preparation(Initial Marketing Authorisation), Post approval Authorizations(Variations, Renewals etc) and Writing Response to Queries for MRP, DCP procedure submission following the timetable

Education

  • Mother Teresa

    M.Pharmacy

    2010 — 2012

Skills

  • Regulatory Requirements
  • Pharmaceutics
  • Pharmacovigilance
  • Gmp
  • Change Control
  • Validation
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Glp
  • Post Marketing Procedures
  • Dossier Preparation
  • Regulatory Affairs
  • Lifesciences
  • Regulatory Submissions

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Sheetal Sarinmai — Senior Regulatory Affairs Associate at Freyr Solutions in Hyderabad, TG, IN | Unifers