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Regulatory Compliance Manager

2 months ago

Richmond Hill, Ontario, Canada Nestlé SA Full time
About the Role

Nestlé SA is seeking a highly skilled Regulatory Compliance Manager to join our team. As a key member of our Regulatory Affairs Operations Team, you will play a vital role in ensuring compliance with regulatory requirements for our natural health products and foods.

Key Responsibilities
  1. Labelling: Develop and implement labelling product lifecycle management processes to ensure business needs are met, including product launches and minimal disruption to product supply.
  2. Change Control: Manage and oversee the change control process for labelling and material change activities, ensuring compliance with regulatory requirements.
  3. SOPs: Develop, implement, and manage Regulatory Affairs Standard Operating Procedures (SOPs) and systems to track and manage technical tasks.
  4. Pharmacovigilance: Lead the preparation of Annual Summary Reports and Issue Related Summary Reports, and conduct literature searches.
  5. Finished Product Specifications & Tolerances: Develop and submit finished product specifications to Health Canada for NHP submissions, collaborating with Quality Assurance and Technical Applications Group.
  6. Strategy & Risk Management:
    1. Develop strategies and cascade instructions to associates.
    2. Perform risk assessments and write investigation reports for deviations.
    3. Communicate challenges to internal and external partners and bring solutions to mitigate risks.
    4. Stay informed about changes in regulations and industry trends to ensure continuous compliance and best practices.
Requirements
  1. A solid scientific background and knowledge of/experience with the regulation of Natural Health Products (NHPs).
  2. Progressive experience in regulatory affairs, regulatory compliance, natural health products, quality assurance, NHP and food labeling, or product development.
  3. Recognized leadership skills and successful line management with direct and indirect reports and exposure across several functions.
  4. Expert knowledge of Regulatory Affairs in both policy and technical practice for natural health products (NHPs).
Preferred Skills
  1. 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. Proficiency in Microsoft Office programs, including Outlook, Excel, Word, and PowerPoint, and the ability to quickly learn other technical databases and resources.
  3. Experience in building and implementing strategy in a particular area.
  4. Experience in crisis management.
  5. Experience with development or support of digital tools is an asset.