Overview

Valeant Pharmaceuticals Canada Regulatory Affairs Manager Contract in Vaughan, ON

Valeant Pharmaceuticals Canada

Branch Vaughan ON CA

Position:
Regulatory Affairs Manager
Location:
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
Posted by: