Manager, Regulatory Affairs

Fresenius Kabi Canada - Toronto, ON (30+ days ago)

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Caring for Life. Make a difference. Be the difference.

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.

We are currently seeking a Manager, Regulatory Affairs to join our growing team!

The Manager, Regulatory Affairs is responsible for the management of regulatory submissions and product life cycle management in the accordance with the current regulatory requirements. The Manager is also responsible for leading a team of Regulatory Affairs Associates (5).

Job Responsibilities:
Responsible for coaching and mentoring team members
Manage all registration and post-marketing maintenance activities
Control prioritization of work of RA personnel to ensure submission timelines are met
Provide regulatory guidance to departments or development project teams regarding development, evaluation, or marketing of products
Present alternatives for meeting regulatory requirements and resolving conflicts between those requirements and manufacturing issues or business needs
Provide guidance to RA Associates for preparation of documentation packages for submission to Health Canada
Liaise with Health Canada personnel, global and regional teams, internal and external organizations such as suppliers
Provide interpretation on complex regulatory guidelines and policies; and delivers training as needed
Manage outside consultants including legal counsel, patent agents, and regulatory consultants on any matter required
Work as a member of a management team to achieve all outcomes
Perform all work in support of our Corporate Values of Costumer Focus, Quality, Integrity, Collaboration and Creativity
Perform all work in accordance with the established regulatory compliance and safety requirements

Job Requirements:
Bachelor of Science (BSc) degree in Chemistry, Pharmacy or Life Sciences, Master of Science (MSc) degree is preferred
Minimum 8 years experience in Canadian pharmaceutical regulatory affairs, with at least 3 years of management experience leading teams
Solid experience with therapeutic products, mainly pharmaceutical
Detailed knowledge of Canadian regulatory requirements
Working knowledge of global (mainly FDA and EMA) regulatory requirements for new submissions and post approval changes to injectable drug product applications
Strong oral / written communication, organizational and interpersonal skills
Computer literate (Proficiency with MS Office specifically)