QA Regulatory Associate
Eupraxia Pharmaceuticals
Victoria, BC
Job Description:
The Quality Assurance and Regulatory Associate is responsible for the upkeep and monitoring of the Eupraxia Quality System, to ensure compliance with GxP and applicable international regulatory standards. In a regulatory capacity, the Associate will also assist in the preparation and maintenance of regulatory submissions and communications. To this end, the Associate will need to keep abreast of evolving changes in the regulatory environment, compliance policies and procedures.

Key Responsibilities

Regulatory

Compiles regulatory submissions and ensures filings to regulatory agencies
Liaises with departments within Eupraxia to obtain data and documentation required for submissions
Tracks progress towards regulatory submissions within established timelines
Maintain regulatory correspondence documentation
Contribute to regulatory budget management
Follow emergence of new regulatory standards and guidelines that may impact Eupraxia products
Perform regulatory intelligence on competitor products
Quality Assurance

Coordinate external audits, internal audits and gap analysis
With guidance, create, maintain and evolve the Quality Management system; oversee and maintain hard copies and electronic databases as appropriate
Coordinate and minute meetings for the Quality Management Committee and Management Review Meeting(s)
Oversee Document Control: Creation, revision, review, approval and control of documents
Review of complaint files, Nonconformity Documentation forms, and corrective/preventative actions
Maintain training system
Requirements

Recognized degree in relevant field (health sciences preferred)
2+ years of relevant experience (or demonstrated abilities) in a pharmaceutical environment
Knowledge of current regulatory guidelines for US, Canada and Europe (strongly preferred)
Quality Systems knowledge (strongly preferred)
General level of computer proficiency – Microsoft Office, Adobe Acrobat and document management systems
Excellent interpersonal, self management and organizational skills
Good technical writing skills

How to Apply:
Please send your CV and cover letter to careers@eupraxiapharma.com .
While only short listed candidates will be notified, we thank each applicant for their submission.