Regulatory Affairs Documentation Specialist

PUB319920

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.

Requirements

Requirements

  • 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.

Benefits

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

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Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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
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Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB319920

Account manager

Chris Kapusta
Brunel Canada - Calgary
c.kapusta@brunel.net

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