Valeant Pharmaceuticals Canada Regulatory Affairs Manager Contract in Vaughan, ON

Valeant Pharmaceuticals Canada

Branch Vaughan ON CA

Regulatory Affairs Manager
Vaughan, ON

Maintain and ensure regulatory product compliance through relevant submissions, active regulatory registrations, device licensing and interactions/negotiations…

Position Summary

We are looking for a Regulatory Affairs Manager with our Bausch & Lomb business unit. This is a 12 month contract/maternity leave position reporting to the Director, Regulatory Affairs.

Key Responsibilities

  • Develop and execute regulatory strategies for timely Health Canada approvals of medical devices, DIN-OTCs and/or NHPs
  • Manage overall regulatory activities for the Bausch & Lomb business unit of medical device and OTC-DIN products
  • Provide regulatory support and guidance to internal/external customers including RA Specialist(s)
  • Function as the Regulatory SME to effectively support local and global QMS audits as well as Corporate audits
  • Plan, manage, and coordinate the preparation, compilation, filing, and approval of high quality regulatory submissions for medical devices and DIN-OTCs to Health Canada
  • Maintain and ensure regulatory product compliance through relevant submissions, active regulatory registrations, device licensing and interactions/negotiations with internal stakeholders and Health Canada
  • Negotiate with Health Canada to ensure prompt regulatory approvals as well as maintenance of filings and certifications
  • Prepare and/or review of responses to Health Canada letters (e.g. Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes)
  • Review Change Controls and execute corresponding filing requirements; provide guidance on promotional materials
  • Liaise with internal and external groups to collect necessary documents and information for regulatory submission and/or compliance

Management Responsibilities

Mentor and provide guidance to Regulatory Affairs Specialist(s) on OTC-DIN and NHP products and filings.

Education/Qualification Requirements

  • Minimum 2 – 3 years of medical device experience in a Regulatory Affairs position; at least 1 year of direct people management experience
  • Previous experience supporting successful QMS audits by regulatory or notified bodies; current knowledge of QMS requirements
  • Completion of a University Degree (Bachelor of Science or equivalent scientific discipline) and Regulatory Affairs Post-Graduate Program; graduate degree is an asset
  • Initiative-driven individual with proven ability to deliver high quality outputs under tight timelines
  • Demonstrated expertise/direct experience in application of Canadian regulatory guidelines to drive commercialization of medical devices and OTC drugs by securing timely product approvals
  • Strong organizational and project management skills including the ability to prioritize projects, coordinate multiple responsibilities for self and others simultaneously
  • Quick learner and team player who thrives in a fast-paced environment with proven ability to manage multiple priorities
  • A sense of urgency, agility, transparency, agility, respect and collaboration in a team setting
  • Excellent communication and interpersonal skills (oral and written)
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint and Outlook) and Adobe Acrobat
  • Bilingual (English and French) is an asset

Job Type: Contract

Required education:

  • Bachelor’s

Required experience:

  • Regulatory Affairs: 3 years

or proceed with Standard Application Form.

Employment Type: Freelance
Location: Vaughan, ON, CA
Posted on: 2017-01-25
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