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Regulatory Affairs Team Lead

2 months ago

Toronto, Ontario, Canada Brunel Full time
{"title": "Regulatory Affairs Team Lead", "description": "Job Summary

Brunel is seeking a highly skilled Regulatory Affairs Team Lead to join our team. As a key member of our regulatory affairs team, you will be responsible for providing leadership and guidance to our Managed Services team, ensuring timely and quality delivery of services as stated in the Statement of Work / Job Descriptions of Managed Service Regulatory Affairs staff.

Key Responsibilities

  • Communicate effectively with the company's Regulatory Affairs (RA) Head and other RA staff to ensure efficient ways of working and coordination of regulatory affairs work in scope.
  • Provide managerial support to the team and direct and supervise daily work.
  • File regulatory submissions to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels.
  • Update the company's internal systems and databases with regulatory affairs information, as per the company's SOPs.
  • Communicate and work with the company's local and global stakeholders, according to the company's SOPs.
  • Prepare SNDS, PRCI, and YBPR regulatory submissions to Health Canada.
  • Interact directly with Health Canada to address questions on filed submissions to ensure approval.
  • Review promotional and non-promotional material to ensure compliance for all products (marketed or development) from the company's portfolios.

Requirements

  • Bachelor's degree in pharmacy or any health-related field.
  • Previous managerial experience.
  • Minimum of 3-5 years previous experience in the preparation of clinical regulatory submissions specific to innovative drugs.
  • French and English (written and spoken) an asset.
  • Strong leadership and decision-making skills.
  • Excellent communication skills.
  • Ability to build effective teams.
  • Excellent understanding of the current Health Canada regulations and guidelines, including publishing eCTD requirements.
  • Computer knowledge of Microsoft Office Suite; Adobe Acrobat.

About Us

Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

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