Regulatory Affairs Associate
Montréal, QC
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.