Regulatory Affairs Specialist Resume Examples

regulatory affairs specialist

  • New Product Registrations with supervision, evaluate, prepare and submit drug registration applications to Saudi FDA
  • Maintained Registered products
  • Medical Device Registration, Renewal, & Update
  • Work on Consumer Health Care Products registration and all related Regulatory activities
  • Involved in Local Manufacturing processes
  • Get engage with Saudi FDA for Local Manufacture process and plans
  • Handle Pharmacovigilance/vigilance reporting, quality complaint and recalls in the region. 

regulatory affairs specialist

  • Reviewed regulatory compliance with knowledge of US regulations (OSHA, DOT, EPA, TSCA), Canada WHMIS, European REACH, and Asia-Pacific GHS for both import and export products 
  • Used SAP to author Material Safety Data Sheets (MSDS) in alignment with the Global Harmonization System (GHS)
  • Assisted in projects to maintain compliance with global hazard communication regulations and related regulatory requirements
  • Provide guidance and approval for artworks development in line with authorities’ requirements and corporate strategies for consumer health care products. 

regulatory affairs specialist

  •  Represented Regulatory Affairs on the Global Business Team Steering Committee (Quality, R&D, Supply Chain, Manufacturing, and Marketing) to navigate difficult, time-sensitive cross-functional issues 
  • Responsible for regulatory compliance of 138 products including US Class I and II medical devices (consumables and hardware/software), FIFRA-regulated pesticide, Canadian and Japanese drug substance, non-medical device hardware complying with EMC and LV Directives and non-regulated medical supplies 
  • Worked with 39 countries globally to support new registrations, re-registrations, and bids; provided CFS, CFG, Certificate of Exportability, Letter of Authorization and various notarized documents as needed 
  • Led four global medical device recalls, 3 out of 4 to closure with successful handoff of the last 

regulatory affairs specialist

  • Ensure compliance with corporate regulatory processes and internal SOP’s. 
  • Provide regulatory intelligence. 
  • Collaborate with logistic team & Distributors to ensure smooth importation and clearance of all products
  • Cooperate with Distributors to ensure all regulatory activities are aligned with Local Authority