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Regulatory Affairs Manager, Team Lead

2 months ago

Canada Nestlé SA Full time
About the Role

Nestlé Health Science is seeking a highly skilled Regulatory Affairs Operations Team Lead to join our team in North York, ON. As a key member of our Regulatory Affairs team, you will be responsible for providing strategic and functional regulatory leadership across the Canadian Nestlé Health Science business.

Key Responsibilities
  1. Labelling: You will be responsible for the ownership of labelling product lifecycle management, ensuring business needs are met, including product launches and minimal disruption to product supply.
  2. Change Control: You will manage and oversee the change control process for labelling and material change activities.
  3. SOPs: You will develop, implement, and manage appropriate RA SOPs and systems to track and manage technical tasks.
  4. Pharmacovigilance: You will lead the preparation of Annual Summary Report and Issue Related Summary Report writing and literature search.
  5. Finished Product Specifications & Tolerances: You will be responsible for the ownership of finished product specifications form submitted to Health Canada for NHP submissions.
  6. Strategy & Risk Management:
    1. You will develop strategies and cascade detailed instructions to associates.
    2. You will perform risk assessment and recommendations & writing investigation reports for deviations.
    3. You will be responsible for communicating challenges to internal and external partners and bringing solutions to mitigate any risks on project level.
    4. You will stay informed about changes in regulations and industry trends to ensure continuous compliance and best practices.
Requirements
  1. You must have a solid scientific background and knowledge of/experience with the regulation of Natural Health Products (NHPs).
  2. You must demonstrate initiative and be proactive; ability to work independently, anticipate needs and be forward-thinking.
  3. You must have a University degree in Science or related discipline. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets.
  4. You must have progressive experience primarily in regulatory affairs, regulatory compliance, natural health products, quality assurance, NHP and food labeling, or product development.
  5. You must have recognised leadership skills and successful line management with direct and indirect reports and exposure across several functions.
Preferred Skills
  1. You must have knowledge of and/or experience in the scientific, clinical and regulatory context of product development, commercialization, and marketing of natural health products and highly regulated food in Canada.
  2. You must have proficiency in Microsoft Office programs, including Outlook, Excel, Word and PowerPoint and the ability to quickly learn other technical databases and resources.
  3. You must have experience in building and implementing strategy in particular area.
  4. You must have experience in crisis management.
  5. You must have experience with development or support of digital tools.
About Nestlé Health Science

Nestlé Health Science is an innovative company engaged in advancing the role of nutritional therapy to improve the management of health for consumers, patients and our partners in healthcare. Our intent is to bring forward nutritional therapies that have proven clinical and health economic value and improve the quality of people's lives. We will support your personal growth with a people-focused culture and a flexible and diverse working environment.