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Jazz Pharmaceuticals

An international biopharmaceutical company headquartered in Dublin, Leinster, Ireland, Jazz Pharmaceuticals has U.S. offices in Palo Alto, California; Philadelphia, Pennsylvania; a

Director, Regulatory Affairs Canada

Location

Canada

Posted

19 days ago

Salary

C$180K - C$270K / year

Seniority

Lead

No structured requirement data.

Job Description

Director, Regulatory Affairs Canada

Jazz Pharmaceuticals

Role 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 - 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). - Provide strategic and operational regulatory input on projects, including: - 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 - Liaise and negotiate with Health Canada regarding drug development, including resolution of key regulatory issues and expediting product approvals and labelling. - Maintain awareness of the global regulatory environment and assess the impact of changes on business and product development programs. - Build partnerships with key peers and senior stakeholders from other functions to ensure strategic business goals are met. - Assist with the development, implementation, and enforcement of regulatory processes. - Support global regulatory in product submissions, market authorization, and label updates. - Support product expansion activities in international markets, such as Middle East, North Africa, Latin America, and Asia Pacific markets. - Support Health Canada inspections as Regulatory Strategy point person. Qualifications - 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 local legislation in the pharmaceutical market, SOPs, policies, and procedures. - Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment. - Regulatory experience with CTAs, NDSs, lifecycle management, and interactions with Regulatory Agencies. - 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. - Proven ability to deliver on goals within a cross-functional team/partnership environment. - Skilled in conflict resolution/negotiation. - Excellent command of English; excellent verbal and written skills. Requirements - Bachelor’s degree; Masters or other advanced degree preferred. Benefits - Extended Health Care - Dental - Long Term Disability - Life Insurance - RRSP - Paid vacation Company Description Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities, and employees in multiple countries committed to serving patients worldwide.

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