347897BR
Jun 30, 2022
Canada

Job Description

100+ approved pharmaceutical products/strengths/dosage forms in Canada, as the Regulatory affairs specialist, you will contribute in the preparation of Canadian regulatory submissions for product registration, progress reports, supplements, amendments, and/or periodic experience reports. You will support registration activities of the Department to ensure compliance with the requisites of the Canadian pharmaceutical regulatory environment.

NO RELOCATION SUPPORT AVAILABLE

Your responsibilities include, but not limited to:
• Prepares, submit and defends various regulatory submissions for new or marketed products at all stages of drug development including Clinical Trial Application (CTA), Supplemental New Drug Submission (S/NDS), New Drug Submission (NDS), and Notifiable Changes (NC);
• Ensures that submissions are accurate, complete and compliant with regulatory requirements;
• Prepare Canadian development/registration strategies in conjunction with the RA Manager and local/global teams;
• Prepares responses to questions raised by Health Canada;
• Prepares and chairs pre-submission meetings with Health Canada;
• Evaluates proposed changes to marketed products for regulatory impact and liaises with internal. stakeholders to assemble necessary documentation;
• Reviews promotional materials;
• Keeps various regulatory tracking tools up to date;
• Prepares and reviews labelling ensuring regulatory compliance. Liaises with internal customers to guarantee proposals are satisfactory and meet their expectations.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:
• MUST BE BILINGUAL - Oral and Written: English and French.
• Bachelor of Science and at least 3 years of Regulatory Affairs experience in the Pharmaceutical Industry, regulatory experience in oncology preferred.
• Knowledge of the Canadian Regulatory Framework for pharmaceutical products.
• Good communication, organizational and time management skills with the ability to multi task.
• Flexible and demonstrated ability to adapt to change.
• Ability to work independently as well as part of a team.
Find out more about Novartis Canada: https://www.novartis.ca/

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
Canada
Montreal
Research & Development
Full Time
Temporary
No
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347897BR

Regulatory Affairs Specialist (Head Office) Temporary 12 months

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