Regulatory Affairs Associate

Job title: Regulatory Affairs Associate

Job description: Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

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.

Qualifications

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.

Preferred

• Advanced degree or higher post-graduate certification in Regulatory Affairs is an asset.
• Minimum 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 knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, 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.

Company: PRA Health Sciences

Expected salary:

Location: Canada

Job date: Thu, 21 Apr 2022 03:24:48 GMT

Job Source: Careerjet.ca

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