Regulatory Affairs, Associate

15 month contract

Job Summary

• Working within Regulatory Affairs, reporting to Head, Regulatory Affairs, Associate, Quality & Regulatory Affairs is responsible for performing the required tasks related to Regulatory Affairs. 

Principal Responsibilities

Regulatory Affairs:

• • Submitting product applications (i.e., DIN, NPN), manufacturing license (DEL, SL) and maintaining Post-DIN Changes, Supplements, Annual Notifications, Amendments, Notifications with Health Canada or other Health Authorities.
  • Coordinate with the Export department the regulatory and quality documents required for product registration.
  • Ensures that the documentation required for regulatory activities is complete, accurate and current.
  • Coordinates documentation requests from Export with other departments involved (as required) and ensures the information is current, accurate and complete within the established timelines.
  • Keep abreast of any changes to Guidelines, Regulations, coordinate communication, training and implementation thereof.

Pharmacovigilance (PV), in collaboration with third party vendor, as needed:

• • Perform literature search and screening on a defined, regular basis.
  • Prepare Annual Summary Reports
  • Submission of expedited single cases to Health Canada. Collection, follow-up and forwarding of spontaneous, literature, solicited, post-marketing adverse event cases, ensure local safety data quality control.
  • Planning and Processing of Aggregate Reports.
  • Preparation and Implementation of new and updated PV Agreements.
  • Support PV Awareness and Training. Develop and maintain of PV SOPs.

Complaints and Queries:

• • Coordination of Adverse reaction reports with relevant departments (e.g., QA, Customer Service, Export, PV third party vendor) to help compile adequate feedback to patients and healthcare professionals, as well as redirect and process adverse events cases, as appropriate.

Requirements – Academic, Experience

• Bachelor of Science, B.Sc., (e.g., Biochemistry, Pharmacology, Biology)

• Minimum 2 years’ experience within Regulatory Affairs, in order to be able to work as independently as possible.

• Familiar with local, regional and any other relevant legislation and guidelines regarding Regulatory (e.g., Health Canada, ICH, USP) and PV (e.g., Health Canada), to fulfill duties.

Other Criteria

• Fluency in both French and English, written and oral.
• Computer literacy and working knowledge of MS Office suite and Adobe Acrobat.
• Effective problem-solving approaches to solve Regulatory and PV issues, while seeking endorsement from Director and/or Manager when necessary.
• Must be able to communicate efficiently with his/her colleagues.
• Ability to review relevant source documentation with attention to detail and accuracy, while managing multiple tasks and prioritizing work in order to meet strict deadlines.