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Position Snapshot

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 Nestle’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

o Develops the strategies and cascades the appropriate detailed instructions to the associates

o Performs risk assessment and recommendations & writing investigation reports for deviations

o Is responsible for communicating challenges to internal and external partners and bring solutions to mitigate any risks on project level. Adapts priorities in response to changing needs. Knows when to act independently or when to call out issues

o 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).

• Demonstrates initiative and is proactive; ability to work independently, anticipate needs and be forward- thinking.

• University degree in Science or related discipline. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets.

• Progressive experience primarily in regulatory affairs, regulatory compliance, natural health products, quality assurance, NHP and food labeling, or product development.

• Recognised leadership skills and successful line management with direct and indirect reports and exposure across several functions

• Expert knowledge of Regulatory Affairs in both policy and technical practice for natural health products (NHPs). Knowledge of other regulated categories (e.g. food for special dietary use (FSDU), infant formula, and/or drug (OTC/Rx)) is an asset

Preferred Skills

• 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.

• Proficiency in Microsoft Office programs, including Outlook, Excel, Word and PowerPoint and the ability to quickly learn other technical databases and resources (including SAP and Veeva Vault)

• Experience in building and implementing strategy in particular area.

• Experience in crisis management.

• Experience with development or support of digital tools is as asset

Benefits

• Comprehensive total rewards benefits package including Health and Dental benefits that start on day one of employment

• Company matched pension plan

• Three/Four weeks of Vacation and four/five/six personal days (Personal Paid Holidays)

• Flexible and hybrid work arrangements

• Excellent training and development programs as well as opportunities to grow within the company

• Access to Educational Assistance & Tuition Reimbursement

• Bonus eligibility

• Free Nespresso Coffee Machines and $100 monthly coffee credit

• Up to 50% off – Nespresso Coffee Machine, Capsules and accessories

• Access to the Discount Company store with Nestlé, Nespresso, and Purina products (Located across various Nestle offices/sites)

• Additional discounts on a variety of products and services offered by our preferred vendors and partnerships

What you need to know

If you believe you have the profile we are looking for, please contact your line Manager before submitting your application and ensure this role is part of your PDP. We will be considering applicants as they apply, so please don’t delay in submitting your application.

Nestlé Canada is an equal-opportunity employer committed to diversity, equity, inclusion, and accessibility. We welcome qualified applicants to bring their diverse and unique experiences as a result of their education, perspectives, culture, ethnicity, race, sex, gender identity and expression, nation of origin, age, languages spoken, veteran’s status, colour, religion, disability, sexual orientation and beliefs.

If you are selected to participate in the recruitment process, please inform Human Resources of any accommodations you may require. Nestlé will work with you in an effort to ensure that you are able to fully participate in the process.