Sr Manager, Reg Affairs

Senior Regulatory Affairs Manager

Burlington Canada office based or remote worker

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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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 people in the sector, and you'll be helping shape an industry.

As Senior Regulatory Affairs Manager within Strategic Regulatory Services (SRS) group, you will:

• Provide comprehensive regulatory services for clients requiring support for registration and maintenance activities for pharmaceuticals and biologics.
• Lead project teams and client meetings to provide regulatory strategy and guidance.
• Prepare/review regulatory submissions (NDS/SNDS/CTA/DIN) in compliance with applicable guidelines and regulations.
• Manage project workflow overseeing progress and completion of projects with team members
• Facilitate success of filings/approvals leading communications and negotiating win-win solutions with project teams, clients and Agency staff.
• Assist and mentor others to build team expertise.
• Supervise staff in effective preparation of regulatory files in adherence with applicable Regulations and guidelines.
• Present services to clients/potential clients to develop new business.

What you need

• Experience of the Canadian regulatory landscape, dealing with the Health Canada.
• Knowledge of Health Canada (NDS/SNDS/CTA/DIN) submissions, good contacts with Health Canada and experience with pre-submission Agency meetings.
• Regulatory/medical writing skills is a strong asset.
• Minimum of a Bachelor's degree in Regulatory/Life Sciences.
• Minimum of 8-10 years of Regulatory experience in Pharma, Biotech, or related industry.

Why join us?

Ongoing development is vital to us, and as the Sr Regulatory Affairs Manager, you will have the opportunity to progress your career to becoming a Director working on a diverse range of therapeutic areas, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

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