Regulatory Affairs Documentation Specialist


About this role

About this role

We’re hiring a Regulatory Affairs Documentation Specialist for our client, a large pharmaceutical company. The role of the documentation specialist consists of preparation of documents and coordination of the activities, both administrative and operational, essentially related but not limited to, regulatory submissions to Health Canada. This opportunity is a contract-based working remote in either Ontario or Quebec.

  • Prepare the administrative documents for regulatory submissions as per current Canadian guidelines and corporate guidance (Health Canada templates, attestation forms, clarifax response templates etc).
  • Ensure timely and efficient management of all submission assembly functions including preparing and/or uploading submission documents and supportive information (such as Document Inventory, cover letters, response to health authorities eTOC) into internal databases for submission or shipment to Health Canada.
  • Dossier management responsibilities (i.e., logging, filing in the appropriate drives and databases, tracking).
  • Organization of electronic documents on shared directories and other electronic media.
  • Management of offsite document storage sending, tracking and retrieval.
  • Act as backup to the Regulatory Affairs Coordinator role (including mailbox overview).
  • Provide support for regulatory activities. Preparation and coordination of courier shipments, archiving procedures and activities, and audit support.
  • Participates in special projects as necessary.



  • Education completed an office administration diploma or equivalent combination of education and experience.
  • 2 years’ experience in the document management area.
  • Experience with Veeva Vault would be an important asset.
  • Verbal and written proficiency with English, French is an asset.
  • Proficiency in PC capabilities including the Microsoft Office Suite and Adobe Suite.
  • Organized, attention to detail and deadline driven.
  • Knowledge of the pharmaceutical industry would be an asset.
  • High level of expertise in all areas of modern office practice and procedures.



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Application process


We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.


After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.


During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.


After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.


Submission of candidates resume for client’s approval and screening.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Chris Kapusta
Brunel Canada - Calgary

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