Are you ready to be part of a dynamic team and working with passionate professionals? If you are excited about growth, innovation, and making a real impact Ipsen is a place for you! Apply now and be part of something extraordinary!
Ipsen is a global specialty-driven pharmaceutical company committed to giving hope to patients with difficult-to-treat diseases and limited options. Our core areas of therapeutic expertise include oncology, neuroscience and rare diseases.
Established in 2015, Ipsen Canada is a member of Innovative Medicines Canada (IMC). Our Canadian operation brings the best of both worlds: the agility of a start-up, backed by the resources and experience of the Global Ipsen Group.
Summary
As a Manager, Regulatory Affairs you will be responsible for leading the development and implementation of the Canadian regulatory strategy, maintaining regulatory compliance and for lifecycle management of Ipsen’s pipeline and marketed products in Canada. Your primary objective will be to oversee the planning and preparation of regulatory filings and ensure timely submission to Health Canada with optimal labelling and approval obtained within designated timelines. This role is also responsible for identifying and evaluating potential regulatory risks, providing guidance to the internal cross-functional team to ensure regulatory strategies align with corporate objectives, and building relationships with Health Canada and other relevant external parties. The role will also provide technical assistance, leadership, and support for special projects and teams as assigned.
Main Responsibilities
Develops and implements the Canadian registration/regulatory strategies
Leads and chairs Health Canada meetings, leading preparation of meeting-related materials and meeting logistics
Leads the planning and preparation of regulatory submissions (NDSs, SNDSs, CTAs, NCs, Level IIIs)
Establishes and maintains close communications and good working relationships with Health Canada, internal cross-functional partners and Global colleagues
Manages the development and implementation of regulatory strategies for all marketed and developmental products
Cross-functional responsibilities include working with various internal departments, including marketing and sales, to identify business opportunities based on changes in the regulatory environment
Supports the identification and evaluation of potential regulatory risks providing guidance to the internal cross-functional teams to ensure regulatory strategies align with corporate objectives
Prepares Product Monograph updates for labelling compliance with Company Core Data Sheets and supports the Ipsen process for artwork label updates
Supports maintenance of SOPs across Regulatory related functional area
Other Regulatory Affairs duties, as required, to ensure ongoing compliance with Canadian requirements and the achievement of applicable goals and objectives
Participates in global, cross-functional and departmental initiatives
Adheres to all corporate policies and procedures
Knowledge, abilities and experience
Bachelor and/or Master’s degree in life sciences or related field (e.g. pharmacology, toxicology, chemistry)
Regulatory Affairs Certificate Preferred
Approximately 5+ years in pharmaceutical Regulatory Affairs
Exceptional communication, interpersonal and organizational skills
Strong leadership skills and ability to work successfully in a cross-functional environment
Ability to manage multiple priorities in a fast-paced environment
Excellent written, verbal and presentation skills
Ability to adapt and be flexible, and ability to balance short and long-term goals
