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
Senior Regulatory Affairs Associate
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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