Regulatory Affairs Project Leader, Artwork

1 week ago

Montreal, Quebec, Canada GSK Full time

Site Name:
Mississauga Milverton Drive, Montreal Queen Street

Posted Date:
Feb 1 2023

Do you have a passion for pack design and ensuring drug labelling are easy to read and understand? If so, this Artwork Coordinator Project Leader opportunity could be the right one for you.

Job Purpose:


As an Artwork Coordinator Project Leader in Regulatory Affairs, you would ensure the packaging labels for all GSK marketed products are kept up to date and easy to read so that patients always have access to the most current information in order to use GSK products in a safe and effective manner.


Details (Your Responsibilities):

  • Initiates, monitors and approves new artwork creation to support new product launches and changes to existing packs for the Canadian market, in alignment with Business needs
  • Represents GSK Canada in artwork related activities. Identify and respond to issues related to artwork development and implementation
  • Proofreads all packaging artwork (English and French) to ensure that it complies with the Regulatory text. Verify all graphical and technical aspects of Canadian artwork (e.g. logos, UPC, security features, etc)
  • Provides input into the planning of submissions, development of submission strategies and works with others to negotiate with Health Canada as it relates to artwork and towards rapid approval
  • Communicates and builds relationships with Global groups involved in the delivery of artwork, LOC (Regulatory, Marketing, Finance, Legal), and External partners on project related plans and issues; communicates and builds relationships with Health Canada
  • Ensures compliance with applicable Health Canada, Industry & GSK codes and guidelines in alignment with business needs
  • Takes lead on assigned projects in other areas or on behalf of the department (as appropriate)

_Why you?_

Basic Qualifications:

  • B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry) and/or degree in packaging technology or similar field
  • 35 years experience in regulatory or in the management of artwork
  • Good working knowledge of the Canadian Food and Drug Regulations, relevant guidelines and policies, with a particular emphasis on Canadian packaging regulations
  • Must have in depth knowledge of global artwork processes
  • Must have a good understanding of commercialization and manufacturing processes
  • Ability to react quickly and provide creative solutions to problems
  • Excellent oral and written communication skills with the ability to present to small and large groups.
  • Able to contribute to the development of regulatory strategies aligned with commercial objectives
  • Good negotiation skills
  • Able to manage multiple projects and tight timelines
  • Ability to work with diverse group of individuals in a team
  • Act with integrity and demonstrate strong commitment to quality mindset
  • Excellent attention to detail and accuracy of work

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Familiarity with Veeva

_ Why GSK?_
_(the following is standard for all job descriptions depending on if the role is "New GSK")_


By 2031, we aim to deliver more than £33 billion in annual sales - a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world.

And we're confident in our future.


Since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients.


In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.


GSK's portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally.

We're prioritising investment in vaccines and specialty medicines, which we expect to grow to around three quarters of our business in the next five years.


Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people.

GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA.


In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation.

General medicines include our inhaled medicines for asthma and COPD, antibiotics and medicines for skin diseases.


Every day, GSK medicines and vaccines protect and improve health, making life better for millions of people all over the world.


Find out more:

Annual Report 2021
**Product Pipelin

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