Regulatory Affairs Specialist

November 26 2018
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs
Laval, QC

Tasks

  1. Regulatory assessments of products
  2. Development of regulatory strategies
  3. Preparation of submission documents of different types: NDS, ANDS, DIN, Medical Devices, PSN, etc.
  4. Preparation and validation of eCTD files
  5. Writing and verification of product labels
  6. Electronic submission to Health Canada
  7. Monitoring the regulatory activities of the different customers
  8. Interaction with Regulatory Authorities for Follow-ups or Questions (Clarifax / Clarimail)
  9. Keeping the regulatory files of the various clients up-to-date
  10. Follow-up with customers
  11. Project management and timeliness
  12. Maintain liaison with the quality assurance department

MINIMAL REQUIREMENTS

  1. Bachelor's degree in science or related field
  2. Minimum 7 years experience in regulatory affairs
  3. Good knowledge of Canadian regulations
  4. Knowledge of eCTD format
  5. Ability to lead multiple projects at once
  6. Ability to work under pressure
  7. Strong organizational and communication skills
  8. Ability to work with minimal supervision
  9. Great flexibility to work on various projects and to meet various customer expectations
  10. Ability to work in a team
  11. Strive for high quality standards
  12. Detail oriented
  13. Excellent French-English bilingualism, spoken and written
Apply now!

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