Brief Description:

The Director, Regulatory Affairs, Canada, is a member of the Global Regulatory Affairs and Drug Safety (GRADS) team and is responsible for providing strategic regulatory direction for designated projects, ensuring that the latest Health Canada requirements and standards are met. The individual will interface with Health Canada and business partners regarding development, regulatory and registration strategies. With a solid reporting line into Global Regulatory Affairs (Regulatory Strategy), the individual will also be a member of the extended Canadian leadership team.  

Principal Duties and Responsibilities:

Canadian Regulatory Lead - Function as a leader in Jazz GRADS and Canada’s extended leadership team and serve as Regulatory Responsible Person.

Act as local regulatory point of contact for the product collaborating with Global Regulatory Lead (GRL) / Global Regulatory Team (GRT):

• Provides, as subject matter expert, strategic and operational regulatory input (including Health Authority Insights) on projects including, but not limited to, Canadian regulatory strategies, regulatory requirements for clinical studies, marketing approval and post-approval activities in Canada, regulatory strategic development plans and risk assessments, critical issue management and advice on Regulatory Interactions with Health Canada.
• In partnership with the Global Regulatory Lead (GRL) and other technical experts, liaises and negotiates with Health Canada, as needed, pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labelling, with clear documentation of discussion and agreements, as directed by line management.
• Maintains awareness of the global regulatory environment and assesses the impact of changes on business and product development programs.
• Builds partnerships with key peers and senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
• Responsible for assisting with the development, implementation and enforcement of regulatory processes.
• Support global regulatory in product submissions, market authorization, and label updates in collaboration with Regulatory Strategy, Global Product Labelling and INSPIRE teams, as applicable
• Support product expansion activities in international markets, such as Middle East, North Africa, Latin America and Asia Pacific markets, as applicable.
• Support Health Canada inspections as Regulatory Strategy point person

Required Knowledge, Skills, and Abilities

• Previous experience of Responsible Person responsibilities in a corporate setting.
• Previous experience of undertaking regulatory submissions, ideally in a corporate pharmaceutical environment.
• Progressive experience within the pharmaceutical industry including Regulatory Affairs.
• Deep knowledge of business and market dynamics.
• Strong knowledge of the local legislation in the pharmaceutical market as well as of SOPs, policies and procedures.
• Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
• Regulatory experience with CTAs, NDSs, lifecycle management, interactions with Regulatory Agencies, and developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Able to understand and optimize internal processes.
• Technical competencies on regulatory and governance linked to the Canadian market and organization
• Proven interpersonal skills with the ability to work collaboratively and flexibly as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
• Problem solving; strong negotiating skills and ability to think creatively and develop creative solutions.
• Excellent command of English; excellent verbal and written skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.

Required/Preferred Education and Licenses

• Bachelor’s degree: Masters or other advanced degree preferred.

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