Shrikant Ojha

  • Mumbai 16

Work History

Work History
Jan 2015 - Present

Officer Regulatory Affairs

Ravenbhel Healthcare Pvt. Ltd.
 Planning, compilation, review and submission of dossiers as per country specific guidelines.  Planning and preparing for Application  Co-ordination with respective departments.  Prepare or maintain technical files as necessary.  Maintaining Product Registration Certificates received.  Keeping records related to Dossiers and samples to different countries.  Checking Artworks of Pharmaceutical Products.  Conversant with current Regulatory Guidelines of dossier Submission.  Timely answering Queries raised by Health Authorities of respective countries and customers.
Jul 2013 - Dec 2014

Quality Assurance cum Regulatory Officer

Shivek Labs Limited
• Regulatory works (Approval & Renewal of Dosage form License, GMP & GLP Certification Form local FDA). • Familiar with government website ( XLN - Xtended Licensing, Laboratory & Legal Node. • Quality trend analysis through CAPA & APQR. • Product Recall • Change Control Process • Cleaning Validation • Issue of Batch Manufacturing Sheet • IPQA activity in Tablet and Capsule Section- Line Clearance, Dispensing etc.) Checking of art work -Preparation of Validation master plan with their validation team and set the validation critical criteria and Re-validations with their verification as programmed with Change control, Deviations, CAPA & Stability/Retention study – Protocol & Reports Preparation (Generic/Specific protocols), Review and Closure with their performance qualification of machine/equipments/system.




Regulatory Affairs

Pharmaceutical Research


Pharmaceutical Industry


2011 - 2013

Master of Pharmacy

University of Pune
2007 - 2011

Bachelor of Pharmacy (B.Pharm.)

RGPV University, Bhopal