Submissions Coordinator

PUB331441

medical device pharmaceutical food industry

About this job

  • Industry: Pharmaceutical
  • Area of expertise: Regulatory
  • Location: MISSISSAUGA

What is required?

  • Hours per week: 40
  • Education level: Other
  • Closing date: Thursday, 20 January 2022

About this role: Submissions Coordinator

About this role: Submissions Coordinator

We’re hiring a Regulatory Submission Coordinator for our client, a multinational pharmaceutical company. The Submission Coordinator provides publishing, word processing and document management activities for the preparation of all regulatory submissions in electronic formats for all products to Health Canada. This is a permanent opportunity with flexible working arrangements based on location. The ideal candidate would preferably be in either Ontario or Quebec.

Responsibilities

  • Provides publishing, word processing and document management activities for the preparation of all regulatory submissions in electronic formats for Canadian products.
  • Manages multiple submissions to ensure Health Canada submission deadlines are met.
  • Inputs cross-references and annotations including hyperlinks when appropriate.
  • Ensures compliance with Health Canada requirements (submission structure, formatting compliance with guidelines and policies).
  • Builds relationships with local/global contacts to facilitate submission efforts.
  • Trains new staff/agency workers.
  • Lead user of many RA systems, identifying business/user requirements, testing and participating in the completion of appropriate computer systems documentation
  • Performs assigned tasks associated with document and regulatory fee management
  • Responsible for maintenance activities on behalf of RA such as custodian or administrator function, providing access control for RA systems, maintaining departmental connect page, creating or updating RA submission templates, managing agency correspondence in RA group mailbox, distribution and posting of Product Monographs, submission planning/assignment of resources
  • Participates and provides input on local RSPS teams, e.g. continuous improvement
  • Reviews projects to ensure compliance with applicable Health Canada, industry & company codes and guidelines in alignment with business needs

Requirements

Requirements

Requirements

  • University/College diploma or equivalent experience, preferably with a strong emphasis in information technology
  • Strong computer expertise including extensive word processing experience; ability to quickly adapt to new technology. Excellent attention to detail and accuracy of work
  • Process improvement mindset and able to react quickly, provide creative solutions to problems, and navigate change.
  • Good oral and written communications skills
  • Accountable to simultaneously work on multiple projects and to meet tight timelines
  • Acts with integrity and demonstrates a strong quality mindset
  • Ability to provide and receive feedback, raise issues, share experiences and lessons learned
  • Collaborative with the ability to work with diverse group of individuals in a team and to express opinions, including as part of group discussions. Open to diverse ideas, styles and perspectives
  • Familiarity with specialized publishing software applications and document management systems
  • Specific knowledge about regulatory affairs and the drug development process
  • Knowledge and experience with CTD submission format
  • Experience with eCTD publishing tools and basic understanding of HTML, XML mark-up
  • Experience with Veeva Vault

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.

About Brunel

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About Brunel

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.

Connecting Specialists to Pioneering Projects

How to apply

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Chris Kapusta via the details below, quoting publication number:
PUB331441

Account manager

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

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