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Lead Regulatory Compliance Manager
2 months ago
Business area: Nestlé Health Science Canada
Location: North York, ON located at 25 Sheppard Ave W, North York, ON M2N 6S8 (Remote)
A little bit about us
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.
What to Expect:
The Regulatory Affairs Operations Team Lead, reporting to the Director of Regulatory Affairs, will be responsible to provide strategic and functional regulatory leadership across the Canadian Nestlé Health Science business, while collaborating across functions to maximize Nestlé’s Regulatory Operations to support patient and consumer outcomes. This role will play a vital part in devising, recommending, and implementing compliant strategies to support business initiatives working closely with the Quality Assurance, Technical Applications Group and Materials Recipes and Management team to accomplish these goals.
A day in the life of a Regulatory Affairs Operations Team Lead:
You will be responsible for the daily operation of the Regulatory Operations team (with 4 direct reports) to manage all labelling activities (including Plain Language Labelling for NHPs and labelling product life cycle management), change controls for labelling and material changes, preparation, review and training of Regulatory SOPs, and lead the preparation of the Annual Summary Report for adverse events.
- Labelling: Ownership of labelling product lifecycle management (process, training and oversight) for natural health products and foods ensuring business needs, including product launches and minimal disruption to product supply, are met. Manages external service providers and stakeholders responsible for the various change steps principally the outsourced certification approvals and label approvals by contract manufacturing organizations.
- Change Control: Manages and oversees the change control process (author, route to internal stakeholders, review the assessments and approval) for labelling and material change activities.
- SOPs: Develops, implements and manages appropriate RA SOPs and systems to track and manage technical tasks. Maintain GMP and SOP training and coordinate training activities (SOP Training) and training record maintenance for all RA employees.
- Pharmacovigilance: Lead preparation of Annual Summary Report and Issue Related Summary Report writing and literature search.
- Finished Product Specifications & Tolerances: Ownership of finished product specifications form submitted to Health Canada for NHP submissions with cross-functional collaboration with Quality Assurance and Technical Applications Group. Provide guidance on regulatory tolerances for foods.
- Strategy & Risk Management: Develops the strategies and cascades the appropriate detailed instructions to the associates. Performs risk assessment and recommendations & writing investigation reports for deviations. Is responsible for communicating challenges to internal and external partners and bring solutions to mitigate any risks on project level. Stay informed about changes in regulations and industry trends to ensure continuous compliance and best practices.
Role Requirements
The candidate must have a solid scientific background and knowledge of/experience with the regulation of Natural Health Products (NHPs).