Contact Information

T: (905) 363-1182 x 253
F: (905) 542-7981

TF: 1 (877) 877-5152 x 253
M: 416.300.8630

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Senior Consultant

Sharifa is a highly skilled professional with over 15 of experience in pharmaceutical regulatory affairs. She brings knowledge of Therapeutic Products Directorate (TPD), FDA, Good Manufacturing Practices (GMP) and ICH, and regulatory compliance expertise. Sharifa's strong organizational, communication, and problem solving skills make her a valuable member of Q&C team. Sharifa has a demonstrated ability to work under tight deadlines, and works effectively both independently and as part of a team. Previous employers include: Apotex and Cangene Corporation (now Emergent Biosolutions)

Skills & Highlights

Regulatory Submissions

  • Compiled number of electronic Common Technical Document (eCTD) submissions for all the major markets Canada, US & EU - Abbreviated New Drug Submission/Application (ANDS/ANDA), and DCP dossiers within tight timelines
  • Responded to deficiencies for all markets pertaining to chemistry, bioequivalence and labelling in collaboration with functional groups (Analytical Development, Formulation Development, Bioclinical and Graphics) identifying the optimum regulatory approach and response strategy
  • Lead projects through life cycle from submission to approval and launch
  • Prepared post-approval supplements, including Supplemental ANDS (SANDS), PAS, CBEs, Notifiable Changes (NC), and annual reports for US and Canada and Variations for EU
  • Prepared and updated labelling for Canada (Product Monograph, Container labels) and US (Prescribing Information, Container labels, Medication Guides, Structured Product Labeling [SPL])
  • Worked on Rest of World (ROW) (Australia, South Asia, Mexico and other less regulated markets) corresponding with the affiliates in filing submissions and post-approval supplements

Establishment licences (Drugs and Medical Devices)

  • Drug Establishment Licence (DEL) management for multinational companies (pharmaceutical and biologics) including amendments, notifications, renewals and foreign site updates and API activities
  • MDEL application, amendments and renewals.

Natural Health Products

  • Site licence applications and renewals
  • Product licence application (ePLA) for monograph and non-monograph products
  • Product licence amendments and notifications

Onsite Project –Clinical Trials (Janssen Inc.)

  • Responsible for the regulatory filing and maintenance of all the clinical studies (approximately 30 studies) for Janssen Inc.to Health Canada. Project included filing of new CTAs, Amendments & Notifications & Response to Health Canada Requests related to the trials.
  • Primary regulatory contact with Health Canada for all Janssen Inc. studies
  • Local Canadian RA representative on Janssen Inc. global study teams

Computer Skills

  • Docubridge (eCTD),
  • Labelbridge (SPL labelling)
  • SAP
  • RIMS (Regulatory Information Management System)
  • MS Office (Word, Excel, Powerpoint)

Awards, Recognition and Achievements

  • Apotex R&D 2007 Team Award

Education

  • Regulatory Affairs (Honors) Postgraduate Certificate, Humber College, Toronto, Ontario
  • Master of Science - Microbiology,Ravishankar University, Raipur, India

Continuing Education, Career Development

  • Foundations of Leadership
  • Train the Trainer
  • Presentation Skills
  • Technical Writing Training
  • Medical Device Workshop (PSG)
  • eCTD Workshop Health Canada (Dec 2017)