Aircraft Regulatory

1 month ago

Old Toronto, Canada Lock Search Group Full time
h3>Regulatory Affairs Manager

Greater Toronto Area

About the job

Our client is a global specialty-driven pharmaceutical company committed to giving hope to patients with difficult-to-treat diseases and limited options. p>

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 their 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

  1. Develops and implements the Canadian registration/regulatory strategies
  2. Leads and chairs Health Canada meetings, leading preparation of meeting-related materials and meeting logistics
  3. Leads the planning and preparation of regulatory submissions (NDSs, SNDSs, CTAs, NCs, Level IIIs)
  4. Establishes and maintains close communications and good working relationships with Health Canada, internal cross-functional partners and Global colleagues
  5. Manages the development and implementation of regulatory strategies for all marketed and developmental products
  6. Cross-functional responsibilities include working with various internal departments, including marketing and sales, to identify business opportunities based on changes in the regulatory environment
  7. 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
  8. Prepares Product Monograph updates for labelling compliance with Company Core Data Sheets and supports the process for artwork label updates
  9. Supports maintenance of SOPs across Regulatory related functional area
  10. Other Regulatory Affairs duties, as required, to ensure ongoing compliance with Canadian requirements and the achievement of applicable goals and objectives
  11. Participates in global, cross-functional and departmental initiatives
  12. Adheres to all corporate policies and procedures

Knowledge, Abilities And Experience

  1. Bachelor and/or Master’s degree in life sciences or related field (e.g. pharmacology, toxicology, chemistry)
  2. Regulatory Affairs Certificate Preferred
  3. Approximately 5+ years in pharmaceutical Regulatory Affairs
  4. Must have regulatory prescription experience
  5. Exceptional communication, interpersonal and organizational skills
  6. Strong leadership skills and ability to work successfully in a cross-functional environment
  7. Ability to manage multiple priorities in a fast-paced environment
  8. Excellent written, verbal and presentation skills
  9. Ability to adapt and be flexible, and ability to balance short and long-term goals

Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted.

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