Medicure Inc. Regulatory Affairs Associate Full Time in Winnipeg, MB

Medicure Inc.

Branch Winnipeg MB CA

Regulatory Affairs Associate
Winnipeg, MB

Experience in Quality Assurance/Quality Control. The incumbent will ensure quality compliance of post-approval activities as per relevant regulations….

Location: Winnipeg, MB
Position Type: Full time
Department: Product Development
Reports to: VP, Product Development & Scientific Affairs

The Regulatory Affairs Associate is responsible for the development of regulatory affairs strategies specific to quality dossiers, and submission and negotiation of regulatory submissions to the United States Food and Drug Administration and Health Canada. The incumbent will ensure quality compliance of post-approval activities as per relevant regulations.

This position will focus on preparing and following up on Chemistry, Manufacturing, and Controls files, as well as work closely with multiple scientific, technical, quality, and commercial areas within the company. This position also works closely with the QA specialist and functions as a backup for QA responsibilities.

General Responsibilities:

  • Providing CMC oversight and regulatory interface with FDA and Health Canada, in strong collaboration with Regulatory Affairs teams
  • Review (including conducting regulatory impact assessments), coordinate and prepare CMC documentation for Prior Approval Supplements, Abbreviated New Drug Applications, New Drug Applications etc.
  • Obtaining and maintaining regulatory approvals
  • Participate as required in project Launch Meetings, Review Meetings and Project Team meetings

Required Skills and Qualifications:

  • Bachelor of Science or Masters of Science
  • Experience with CMC modules I, II, III
  • Experience with CMC generic submissions
  • Detail oriented person, with strong capability to multi-task
  • Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset
  • Ability to work well both independently and in a team environment
  • Solid decision making skills with strategic mindset
  • Excellent communications skills (verbal, written, listening, conveying messages)
  • Solid computer skills, using MS Office, MS-WORD and Lotus Notes
  • Experience in Quality Assurance/Quality Control
  • Experience with eCTD and non-CMC regulatory affairs is an asset
  • Based in Winnipeg, MB.

Company Description:
Medicure Inc. is a specialty pharmaceutical Company engaged in the research, clinical development and commercialization of human therapeutics. The Company’s primary focus is on the sale and marketing of its acute care cardiovascular drug, AGGRASTAT® (tirofiban hydrochloride) in the United States and its territories through its U.S. subsidiary, Medicure Pharma Inc.

Job Type: Full-time

Required education:

  • Bachelor’s

Required experience:

  • Regulatory Compliance: 1 year

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Winnipeg, MB, CA
Posted on: 2016-09-22
Posted by: