Regulatory Affairs Specialist (pharmaceutical)

Vancouver, BC, Canada

Job Description

Who Are We?The drug overdose crisis continues to have devastating impacts on Canadian communities and families through high rates of overdoses and deaths. FairPrice Pharma aims to tackle this issue head on by providing an alternative to the toxic illegal drug supply though prescribed medications with the goal of preventing overdoses and saving lives!Key Responsibilities

  • Knowledge and experience with NDS and ANDS.
  • Experience in work with ICH modules.
  • Knowledge and ability in the use of eCTD software.
  • Can lead pharmacokinetic studies and phase 4 studies.
  • Experience in conducting stability and shelf-life studies.
  • Research, organize, and produce regulatory reports.
  • Review research, protocols and drug master file data.
  • Excellent communication skills and tact in discussions with Health Canada.
  • Superb and concise writing skills for submissions,
Knowledge, Experience and Skills:
  • Strong organization skills along with the ability to work on a complex project with tight timelines is required.
  • Attention to detail with accuracy and quality is a must.
  • Strong verbal and written communication skills and interpersonal skills are required.
  • Must be proficient in Microsoft Word. Proficiency with Microsoft Excel and PowerPoint is preferred.
  • Critical thinker and problem solver.
  • Ability to distil concepts with many moving parts to an organized and simplified process.
  • Prepare high quality submissions as well as develop risk-based strategies on
  • Experience with FDA and EMA submission an asset.
Job Types: Full-time, PermanentSalary: $70,000.00-$80,000.00 per yearAdditional pay:
  • Bonus pay
Benefits:
  • Casual dress
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Life insurance
  • On-site parking
  • Paid time off
  • RRSP match
  • Wellness program
Schedule:
  • 8 hour shift
  • Monday to Friday
  • No weekends
Ability to commute/relocate:
  • Vancouver, BC: reliably commute or plan to relocate before starting work (required)
Education:
  • Bachelor's Degree (preferred)

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Job Detail

  • Job Id
    JD2022300
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Vancouver, BC, Canada
  • Education
    Not mentioned