Experience

Quality Smart Solutions

• Canada
• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Affairs and Quality Assurance Specialist

  • Mar 2022 - Present

  • Preparing and submitting natural health product license applications (class I, II and III), notifications and amendments for the clients. • Preparing and submitting Site License Applications, notifications, and amendments for the clients. • Preparing and submitting responses to Clarimails and information Request Notices (IRNs) issued by NNHPD for the site and product licences applications. • Reviewing and assessing safety and efficacy evidence (publications research) for product licence application using online databases as PubMed, Cochrane, Google Scholar etc. • Compiling and Submitting Cosmetic Notification Forms (CNFs) for cosmetic products. • Reviewing label content and artwork for NHPs and cosmetics in accordance with the current labelling guidelines issued by Health Canada and ensuring label compliance. • Communicating with regulatory agencies on an ongoing basis regarding regulatory issues, compliance requirements, general queries regarding ingredient databases, follow-up on existing submissions for the clients. • Engaging with clients to answer questions and inquiries related to Natural Health Product Regulations and Cosmetic Regulations. • Preparing and presenting seminars/webinars for the purposes of cross-functional training of the team members. • Preparing and Reviewing Standard Operating Procedure (SOPs), records, Corrective & Preventative Action (CAPA) reports, Out of Specification Reports (OOS) deviation reports for the clients. • Conducting background research, gathering input from stakeholders (clients) and developing written briefs on assigned regulatory issues for seeking clarifications from Health Canada. Show less



PM International

• Luxembourg
• Wellness and Fitness Services
• 700 & Above Employee

• Quality/Regulatory Affairs Associate

  • Sep 2020 - Mar 2022

  • Ensuring that Natural Health Products (NHPs) and Cosmetics are imported, warehoused, packaged, labelled, and marketed in Canada in accordance with Health Canada guidelines. • Acting as primary interface to NNHPD (Health Canada) for regulatory issues, filings, amendments/modifications of product registrations for Natural Health Products and Cosmetics. • Filing Product Licence Application (Class I, II and III NHP PLA) for new products and Amendment Notification Forms (ANF) as required for existing approved products. • Compiling responses for information Request Notices regarding the site and product licences and communicating with NNHPD. • Reviewing and assessing safety and efficacy evidence for NHP product licence applications using online databases as PubMed, Cochrane, Google Scholar etc. • Performing literature search for registering new ingredients using ingredient issue forms. • Initiating and Submitting Cosmetic Notification Forms (CNFs) for cosmetic products. • Filing Site Licence Application (SLA) and submitting amendments as required for necessary post-approval changes. • Communicating with regulatory agencies regarding regulatory issues, compliance requirements, general queries regarding ingredient databases, follow-up on existing submissions. • Reviewing and approving claims, label content and artwork for NHPs and Cosmetics in according with labelling guidelines issued by Health Canada while coordinating with graphics department. • Preparing and Reviewing SOPs, Corrective and Preventative Action (CAPA), Out of Specification Reports (OOS) deviation reports and change control as required. • Reviewing all Finished Product documents (NHPs and Cosmetics) -Certificate of Analysis (CoA) and Certificate of Manufacture (CoM) of raw materials/finished products governing release for sale as per Canadian requirements. Show less



Accuristix

• Canada
• Transportation, Logistics, Supply Chain and Storage
• 100 - 200 Employee

• Order Processing and Returns Specialist

  • Sep 2019 - Sep 2020



S.K. Appliances

• India

• Quality Assurance Supervisor

  • Jan 2014 - May 2019