Rashmi Sharma is a congenial, hard-working, adaptable professional with excellent organizational and problem-solving skills and experience in regulatory affairs, quality assurance and pharmacovigilence. She has regulatory and scientific knowledge, strong analytical skills and excellent communication, presentation and team work abilities. She is able to manage multiple projects, prioritize and meet tight timelines.

Regulatory

• Prepared Notifiable Changes and Clinical Trial Applications
• Assisted in preparation of Submissions including Supplemental New Drug Submissions and Establishment Licence/DIN Applications
• Reviewed Product Labels and Advertisement dockets from Marketing
• Prepared various post-marketing requirements (i.e., annual updates, monthly product commitments, yearly biologic product reports, licence amendments). Prepared and submitted design dossiers, screening deficiencies and Request for Additional Information from Health Canada for medical device applications (Class II-IV Applications, Amendment Applications)
• Updated Product License Commitments (PLCs) for International countries
• Completed product Renewal submissions
• Responded to questions from Regulatory Authorities and Distributors
• Completed Post Approval commitment submission to CBER

Quality Assurance

• Ensured compliance with Canadian Medical Device regulations and interpretations
• Worked on Change Assessments for Medical Device products
• Managed tracking and reconciliation of physician samples for Sales Representatives
• Compiled specific manufacturing and release data to support the preparation of reports such as annual product reviews, validation summaries, investigations and trend evaluations

Pharmacovigilence

• Submitted Therapeutic Adverse Drug Reports and Medical Devices Problem Reports (Safety reports) to Health Canada

Technical Writing

• Reviewed technical documentation for product release, development of procedures and maintenance files in compliance with Canadian GMPs
• Assisted in the development of new SOPs and revision of existing SOPs to ensure continued GMP and corporate compliance

Education

• Pharmaceutical Regulatory Affairs & Quality Operations (RAQC) Post-Diploma, Seneca College, Toronto, Ontario
• Bachelor of Science, McMaster University, Hamilton, Ontario

Continuing Education, Career Development

• GMP training certification (sanofi)
• ISO certification training (sanofi)
• eCTD training (sanofi)