Budding Talent Partners LLC

Regulatory Affairs Manager

Budding Talent Partners LLC - Toronto, Ontario

Our client is a publicly traded cannabis operator based in Ontario with operations in multiple provinces.

Responsibilities:

  • Provide advanced level electronic publishing, word processing and document management support for the preparation of all regulatory submissions in paper and electronic formats.
  • Assist in the preparation and peer review of components of regulatory submissions for various markets to ensure timely approval; including review of labeling material.
  • Maintain document trackers and progress on aspects of product development, submission and inspection logs
  • Legislative and regulatory tracking and strategy for cannabis updates on a local and global level; Own database of cannabis regulations and become the in-house cannabis regulatory expert.
  • Create approach documents to conduct protocol driven studies as necessary, e.g. Stability Programs
  • Perform quality control checks on reports and submission documentation for consistency with submission standards, regulatory guidance, company Standard Operating Procedures.
  • Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
  • Liaise with other functional areas to resolve issues related to information for regulatory submissions.
  • Effectively maintain regulatory databases to ensure accuracy of information.

Qualifications:

  • Minimum Bachelor's degree or equivalent.
  • Minimum five years experience in the pharmaceutical industry with focus on product, submission compilation and technical writing
  • Detailed knowledge of multiple regulatory requirements e.g. FDA, EU, HC, etc.
  • Excellent oral/written communication, leadership, organizational and interpersonal skills
  • Must possess a passion for cannabis products and services and the cannabis industry in general, while providing excellent regulatory advice in line with the current regulations.
  • Strong team player with demonstrated ability to work in a plant as well as virtual setting


Posted On: Thursday, November 21, 2019



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