Regulatory Affairs Assistant

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Regulatory Affairs Assistant

The Regulatory Affairs Assistant's main purpose of this position is to ensure that MEDISCA is holding the appropriate licenses, responding to Department requests, updating federal regulatory listings and various administrative work for the department.

If you are an enthusiastic self-starter, goal driven, love regulatory affairs and have an interest in the pharmaceutical industry, then we are looking for you!

The opportunity:

  • Maintain Licenses for all facilities (Canada, United States, European)
    • Apply/renew licenses
    • Obtain proper documentation; track progress of licenses
    • Learn the different licences and its conditions

  • Administrative Work for the Department
    • Maintain logs
    • Organize files and records
    • Keep the department updated with current regulations
    • Update SOPs from a regulatory perspective

  • Requests from Departments
    • Write letters to customers when they are requesting specific company inquiries
    • Help sales representatives with specific requests and answer their customers' questions
    • Assist on any other requests (Purchasing, Quality, R&D, Marketing)

  • Prepare Regulatory Reports
    • Adverse Drug Reaction reporting
    • Monthly State reports
    • Requests from government agencies (Subpoenas, GMP Requests)
    • Loss/Theft Reports

  • Update and Maintain Regulatory Federal Requirements
    • Establishment and Drug Listings with Food & Drug Administration (FDA)
    • Drug Establishment licenses with Health Canada

TRAVEL: Up to one (1) week of daily travel per year to attend audits and visits other MEDISCA facilities.

Required Skills:
  • Excellent communication skills; fluent English and French (oral & written) required
  • Proven abilities in time management and organizational skills
  • Applied discretion in his/her work; reliable
  • Knowledge of Microsoft Office (Word, Outlook, Excel, and PowerPoint), Syspro an asset
Required Experience:
  • Minimum one (1) year experience in a regulatory or quality control environment
  • Bachelor's degree in a Science related field
  • Knowledge of CGMP's, FDA, DEA and Health Canada regulations required

Be a part of our winning team and take advantage of the opportunity to excel in an exciting career that helps make a difference in the lives of millions of people through MEDISCA and the pharmacy compounding industry. Apply now for the Regulatory Affairs Assistant position.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.


Company Overview

MEDISCA Pharmaceutique Inc is an FDA (Food and Drug Administration) registered supplier of fine chemicals, which include: - Active pharmaceutical ingredients (APIs) - Excipients in the form of bases, oils, colors, and flavors - Reusable and disposable devices for compounding pharmacists across the United States, Canada, Australia, and Europe. MEDISCA Pharmaceutique Inc is committed to bringing to the pharmacy compounding community the highest quality fine chemicals, compounding supplies, compounding solutions, and training.

MEDISCA Pharmaceutique Inc's trusted partner and educational arm, MEDISCA Pharmaceutique Inc NETWORK supports ACPE-Accredited pharmacy compounding training programs: Certificate Programs in Pharmacy, workshops, and symposiums. MEDISCA Pharmaceutique Inc NETWORK's Technical Support Services Department provides customized and on-line formulas, along with a customer service help line to answer compounding-related questions regarding compounding equipment, compounding scripts, and compounding medications.

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