Regulatory Affairs Specialist (Remote) (Health Canada exp)

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

What You Will Be Doing:

• Management of activities associated with applications for drug, biologic, medical device, NHP clinical trial activities in Canada, including initial, amendment which require approvals from Health Canada as well as notifications to Health Canada.

• Ability to prepare QOS, PSEAT, CTSI, Application forms etc to complete submissions for Initial Clinical Trial Applications, amendments and notifications, with a strong working knowledge of Health Canada Guidance for Clinical Trial Sponsors: Clinical Trial Applications.

• Management and maintenance of responses to Health Canada submissions per Canadian requirements, Regulations, Guidance etc.

• Ensuring that IP labels are in adherence with Health Canada labelling requirements and submitted if applicable.

• May support, prepare and review GMP and product (drug products, medical devices, cosmetics, food, NHP) submissions for product registration and maintenance to Health Canada with appropriate oversight, supports promotional material activities based on relevant regulations and updates regulatory systems accordingly.

• Management of the Informed Consent and any other patient facing documentation which may be included in submissions and may require approval by Health Canada.

• Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF, and other applicable ICON systems.

• Perform role of Local Reviewer in the QC process.

• Providing consultancy to the client on any Health Canada/Canada specifics issues if requested by the Start-Up Lead (SUL), Global Regulatory Affairs Lead (GRAL), Clinical Team Manager (CTM) or Project Manager (PM).

• Attending internal and external project team meetings as determined by the Functional Manager (FM), GRAL and study teams.

• May submit safety reports to Health Canada in accordance with Health Canada's Food and Drug Regulations and the project-specific contractual agreement.

• May serve as Regulatory Intelligence Consultant for Canada.

• Supporting the Senior level Regulatory Intelligence Consultant for Canada in the maintenance of the accurate, up to date Knowledge Repository for Canada.

• Contribute to the maintenance and collection of Regulatory Intelligence for Canada by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date for Canada; communicate new information or changes to the Regulatory Intelligence Consultant team for Canada.

• May liaise with team/other department members to validate Country Intelligence for Canada before liaising with the appropriate GRA team member to ensure that the information is disseminated appropriately.

• May work with Global Regulatory Affairs team members to provide Regulatory consulting services .

• Provide support, mentoring and training within regulatory team where required.

• Any other duties deemed necessary to secure the success of ICON's business.

What You Need to Have:

Minimum Requirements

• Bachelor's degree or its international equivalent in science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) is required. (With Director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.)

• Strong knowledge of current ICH Guidelines, Health Canada Food and Drug Regulations, Food and Drug Acts, Health Canada Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other Canadian requirements as they relate to pharmaceutical, biological, biosimilar, NHP and medical device product development.

• Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.

• Excellent verbal and written communication skills, and interpersonal skills are required.

• Excellent organization skills and ability to work with multiple projects/timelines.

• 6+ months of experience preparing and compiling initial CTA, CTA-A, CTA-N for Health Canada is preferred.

Preferred

• Advanced degree or higher post-graduate certification in Regulatory Affairs is an asset.

• 2+ years prior experience preparing and compiling initial CTA, CTA-A, CTA-N for Health Canada is preferred.

• Strong knowledge of current Canadian requirements and guidelines is preferred, as well as the ability to understand new guidelines and regulations as they are issued by other major regulatory authorities that may be relevant to Canada.

• Bilingual in French is an asset.

• CRO experience is preferred.

This is a home-based position anywhere in Canada

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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