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.
- 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.
- 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
Thursday, November 21, 2019