Regulatory Affairs Associate



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Regulatory Affairs Associate

The main purpose of this position is to ensure that Medisca Inc. and MEDISCA Pharmaceutique Inc. are in compliance with the regulations set forth by the FDA, Health Canada, TGA, EU.

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:

Ensure Compliance within All Facilities and markets (Canada, US, EU, Australia)

  • Keep updated with all State, Provincial and federal Regulations
  • Research and interpret regulations
  • Attend seminars, webinars and meetings hosted by Regulatory Bodies
  • Create Regulatory Guides and train appropriate personnel
  • Ensure SOPs are compliant with applicable regulations through Change Request Approval
  • Develop and implement regulatory strategies to ensure compliance with current and upcoming changes to regulations
  • Serve as internal key contact for all issues pertaining to controlled substances.
  • Coordinate recalls and product issue
  • Build relationship with Regulatory Agencies

Review and observe worldwide regulatory guidelines.

  • Assess products under strict guidelines and keep proper documentation.
  • Track and maintain regulatory correspondence and submissions.
  • Liaising with various internal and external groups to collect necessary documents/information for compliance

Involved in Regulatory Support for company by working with other departments

TRAVEL: Up to two (2) weeks per year to attend conferences

Required Skills:

  • Excellent communication skills; fluent English, good French (oral & written)
  • Knowledge of FDA and Health Canada regulations is required
  • Reliable, accountable, detail-oriented
  • Organized, very good judgment and decision making skills
  • Knowledge in project management
  • Good command of Microsoft Office (Word, Excel, Outlook)
Required Experience:
  • Bachelor of Science and minimum five (5) years of experience in Quality Control or Regulatory Affairs

Why work for MEDISCA:

  • We strive to recruit the best talent
  • We are committed to developing excellence in all our employees
  • We offer excellent benefit package, a competitive salary as well as excellent career growth opportunities in a fast growing company

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 Associate 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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