Regulatory Affairs
Toronto,ON
Summary
Seasoned Regulatory Affairs Professional with over 5 years’ experience working in areas of Regulatory submissions, post market surveillance, Research and Development, Medical writing, and Quality Assurance. Completed Post Graduate Certification program in Regulatory Affairs. Excelled in process improvements to assist product development in meeting regulatory requirements for Drugs, Medical Devices and Cosmetics. Excelled in the maintenance of records of regulatory information and submissions. Trained to address domestic and international regulatory statutes and laws. Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Looking for a challenging opportunity to leverage my technical experience, Regulatory Skills and my Quality background to make a significant impact and bring value to organization.
Overview
1
1
Certification
17
17
years of professional experience
Work History
Regulatory Affairs Specialist
Apollo Health and Beauty Care
Toronto, ON
07.2020 - Current
- Preparation of CTD Modules for submission to Health Canada for establishing the DIN for the OTC products
- Preparation of 16 sections of the SDS as per the GHS guidance while ensuring SDS compliance with OSHA standard and compliance
- Guided the team in getting Cosmetic GMP compliance as per ISO 22716
- Authored standard operating procedures and work instructions
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors
- Coordination of recall or market withdrawal activities as necessary
- Interpretation of regulatory rules and changes while maintaining communication with relevant stake holders
- Preparation of the Ingredient listings, calculation of Percentage of Active and Non active ingredients
- Verification of the labels for Health Canada and US-FDA compliance on Cosmetics and Cosmetic Labelling
- Tie up with Cosmetic alliance for the submission of Free Trade Agreements, Notarizations, and attestation for export to Latin American countries
- Approval of contract labs for several testing regimes against covid-19
- Ensures appropriate supporting analysis and documentation for regulatory compliance to validate/support claims
- Establishing the Cosmetic notification and the Voluntary Cosmetic Reporting Program
- Perform Customer complaints-initiated Pharmacovigilance of OTC and Cosmetic products as per the regulatory requirements.
Regulatory Affairs Consultant, Submission Specialist
Regulatory
Toronto, ON
11.2019 - 06.2020
- Aided clients to navigate the comprehensive Cannabis Regulations in Cannabis Tracking and Licensing System (CTLS) such as the completion of Arial views, completion of OSPs, Key investor reports, Physical Security Report, etc
- Created SOP's for clients, formulated GAP analysis and enlisted all SOP's required for successful submission of applications
- Prepared Notice to Local Authorities, List of key site personnel members along with the Security clearance details, Good Production Practice as per Part 5 of the Cannabis Regulations
- Provided technical support to clients to manage operational readiness for cultivation as well as processing built up areas.
Regulatory Affairs Consultant, Regulatory Submission
Riyadh, Saudi Arabia
07.2014 - 07.2017
- Facilitate the preparation and submission of responses to Clarimails from Health Canada within a very tight timeframes specified
- Successfully completed part of the submission process requirements for a class IV Medical Device
- Assisted clients remotely in the completion of the 5 modules of the CTD dossier for electronic filing to the FDA and Health Canada
- Filed Health Canada notifications, inspection responses and all other correspondence between the client and Health Canada
- Consulted and advised clients on wrong strategies, particularly, design flaws thus saving millions of dollars
- Advised clients on construction design, man-material movement, GMP requirements for laboratory and SOP content.
Quality and Regulatory Affairs Specialist
Central Military Hospital, Blood Bank
Riyadh, Saudi Arabia
01.2016 - 07.2017
- Prince Sultan Military Medical, Achieved JCI accreditation by leading a team through audit meetings, operating plans through SOP's, provided guidance to emerging regulatory issues that was appreciated by the management by receiving an excellence award
- Led investigations on Quality Issues, generated around 6 KPI's, used analytical skills to improve the performance level from 60% to 90% achievement level and sustained this level
- Ensures that QC/QA/RA functions across all areas of the company are meeting high standards of performance that meets company demands and performance expectations
- Conducted audits to measure compliance to guidelines for GMPs and GDPs, ensured proper corrective action was taken
- Administered the CAP proficiency testing program, verified precision and implemented CAPA for out of precision values
- Performed 4 audits/inspections along with a lead auditor
- Received extensive training from JACIE in being a Stem Cell auditor
- Provided monthly reports to the CQI on the Quality parameters apart from presentation to the Quality staff of various departments.
Consultant Clinical Scientist
Stem Cells, Central, Blood
07.2012 - 07.2017
- Bank, Prince Sultan Military Medical, Planned, executed all operational procedures, authored over 20 SOP's, guided and trained staff in technical operations, of the CML and Blood Bank
- Led initiatives to complete all compliance issues of equipment's as per the JCI guidelines and made sure that 100% of Compliance was met by introducing New Key Performance Indicator (KPI) projects
- Communicated with various stage holders such as purchasing committees, medical staff from the transplantation and gynecological unit and various other departments such as Quality and Finance
- Set up company-wide quality manual that is called as a Quality matrix
- Created and maintained a well-established document Management system for all the stem cells stored in the facility
- Trained over 50 staff members on various aspects of the SOP and documentation, monitoring the progress of staff and give yearly appraisals for staff's contract renewal.
Director
Stem Cell Laboratory, UniStem BioSciences Pvt Ltd
Gurgaon, India
03.2009 - 07.2012
- Prepared dossier that involved consolidation of over 30 Stem Cell SOPs such per the Foundation of Accreditation for Cellular Therapy (FACT) guidelines
- Conducted over 5 audits of vendors supplying equipment's to ensure specifications as per requirements
- Saved the company an excess of $100,000 while negotiating with various stakeholders, consultants, company representatives
- Managed security in the secure cryopreservation area by preventing unauthorized access through cameras and access card usage.
Education
Post-Degree - Regulatory Affairs
Humber College
2019-08
Diploma - Medical Laboratory Science
Anderson College of Health, Business And Technolog
2018-09
Ph.D - Immunology
Kasturba Medical College
2003-05
Master of Science - Biochemistry
Goa Medical College
1997-05
Bachelor of Science - Chemistry
St. Xavier's College
1994-05
Skills
- Communication & Negotiation
- Attention to Detail
- Technical writing
- Critical Thinking
- Regulatory Knowledge
- Regulatory Submission
- Scheduling and Organization
- Interpersonal skills
- Time Management skills
Accomplishments
- Regulatory Submission-Submitted over 50 Drug applications as part of the Regulatory submission process, successfully negotiated with the regulatory agencies through astute planning and communication and achieved a success rate of 100%
- Effective Collaboration-Was part of the team in creating an effective Dug and Medical Device application process that was highly acclaimed by peers and coworkers
- Collaborated with various stakeholders such as Product Development, R&D, Sales and Marketing in completing all aspects of Regulatory Compliance
- Excelled in Collaborative Regulatory tasks with over 15 clients such as Costco, Walmart, Walgreens, Dollar General, Giant Eagle, etc
- Research and Development-Achieved a remission rate of 95% in Transplantation from a previous rate of 73% through the invention of a new mathematical formulae that was published in a highly acclaimed Journal
- Compliance resolution-Resolved Regulatory issues on label compliance, mitigated compliance issues on Ingredient listings by effective communication, extensive research, and targeted response
- Management-Supervised team of 30 staff members and achieved a successful and timely completion of projects, CAPA’s and KPI’s
- Project completion and presentation-Undertook 6 KPI’s, preformed Root Cause Analysis, increased efficiency by 20%, compiled and presented data to Quality representatives
- Permanently mitigated compliance issues through planning and modification of SOP’s
- Technical writing- Published over six articles in highly acclaimed peer reviewed journals
- Published a chapter of a book on preparation of SOP’s for PhD scholars in a highly reputable springer publication
- Authored over a 100 SOPs, reports and work instructions in the last 7 years.
Certification
2014-05
Lean Six Sigma Green Belt Certification (Accredited by ASCB Europe)
2018-10
Canadian Society for Medical Laboratory Sciences (CSMLS)/ Medical Laboratory Professionals' Association of Ontario (MLPAO)
2018-12
MLPAO Medical Laboratory Assistant certification exam
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Timeline
Regulatory Affairs Specialist
Apollo Health and Beauty Care
07.2020 - Current
Regulatory Affairs Consultant, Submission Specialist
Regulatory
11.2019 - 06.2020
Quality and Regulatory Affairs Specialist
Central Military Hospital, Blood Bank
01.2016 - 07.2017
Regulatory Affairs Consultant, Regulatory Submission
07.2014 - 07.2017
Consultant Clinical Scientist
Stem Cells, Central, Blood
07.2012 - 07.2017
Director
Stem Cell Laboratory, UniStem BioSciences Pvt Ltd
03.2009 - 07.2012
Bachelor of Science - Chemistry
St. Xavier's College
Master of Science - Biochemistry
Goa Medical College
Ph.D - Immunology
Kasturba Medical College
Diploma - Medical Laboratory Science
Anderson College of Health, Business And Technolog
Post-Degree - Regulatory Affairs
Humber College