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Harshini P. - 21900
Windsor, Canada
5:52 AM, GMT -05:00
Harshini P. - 21900 Regulatory Affairs Officer from Windsor
About
• Offering 13+ years of Experience in Finished formulation
• CMC review and submission
• Strong knowledge of cGMP and ICH guideline
• Regulatory guideline exposure of more than 40 countries
• Dosage form handled are Oral Dosage (Tablet, Capsule, Syrup), Parenteral (SVP, LVP, Ophthalmic), Topical (ointment), Natural products
Occupation
Regulatory Affairs Officer
Work experience
2022 - 2022
Manager - Regulatory Affair
JAMP Pharma
Education
2011 - 2013
Sikkim Manipal University
Master of Business Administration
2003 - 2007
Devi Ahilya Vishwavidyalaya
Bachelor of Pharmacy
Skills
ASEAN
13 Y
Change Management
13 Y
Dosage Forms
13 Y
drug development
13 Y
EMEA
13 Y
English
13 Y
External Stakeholders
13 Y
Microsoft Office
13 Y
Prioritising
13 Y
Project Management
13 Y
Regulatory Affairs
13 Y
Spanish
13 Y
Team Building
13 Y
Teamwork
13 Y
Time Management
13 Y
Other skills
Annual Product Quality Review
Batch Release
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