Regulatory Affairs Lead

Location: bowmanville, ON, Canada
Date Posted: 08-31-2017
Our client, a Canadian leader within the consumer pharmaceutical space is looking for a Regulatory Affairs (RA) Lead that will lead the team to oversee and enforce regulatory compliance. This opportunity is located in the east end of Toronto.
 
Responsibilities:
  • Ensuring products comply with the Canadian Acts, Regulations, and associated policies within the federal and provincial government
  • Stay current with Regulatory changes happening in Canada and within the provinces
  • Oversee and manage regulatory inspections, product transfers, RPICs, security incidents, loss/thefts, adverse reactions, product destruction, and non-conformances
  • Liaison with regulatory officials, preparation of regulatory submissions, and coordination of responses to Health Canada
  • Review of product labels and advertising
  • Produce and/or manage the yearly, quarterly, monthly and other inventory control related reports as required by the ACMPR
  • Manage the preparation and implement of Standard Operating Procedures
  • Responsible for management of site-specific document control functions
  • Manage regulatory team within the company and provide management support to the Director Regulatory Affairs when needed 
  • May be requested to assist with international regulatory functions, on an as requested basis 
  • Other duties, as assigned
 
Requirements:
  • Bachelor’s degree.
  • A minimum of 5 years of Regulatory Affairs experience within a Pharmaceutical organization.
  • Experience working with Health Canada and lead the Health Canada Audits.
  • Experience writing Standard Operating Procedures (SOP) and taking corrective action.
  • Experience with Good Manufacturing Practices (GMP) and Quality Systems experience. 
  • Demonstrated experiences in prioritizing tasks and simultaneously handle multiple projects.
  • Excellent communication, written and interpersonal skills.
  • Strong ability to analyze and synthesize data to find solutions.
  • This individual must be able to work independently and must be able to manage a team and a tight regulatory process/environment.
 
This is a career role, not just another job. To express interest in this opportunity, please contact Rebecca Liu at rebecca.liu@thetalent.co. As always, referrals are gratefully received.
 
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