Regulatory Affairs Manager
3 weeks ago
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:
This role will provide strategic and functional regulatory leadership across the Canadian Nestlé Health Science business, while collaborating across functions to maximize patient and consumer outcomes. The candidate must have a solid scientific background and knowledge of/experience with the regulation of Natural Health Products (NHPs).
A day in the life of a Regulatory Affairs Manager:
You will be responsible for ensuring that our NHP Brands are safe, compliant and attractive. You will drive regulatory activities, provide value-added regulatory strategies cross-functionally across the Health Science business, and contribute to the Innovation & Renovation process.
You will also:
- Act as business partner to all relevant functions (i.e., Marketing, Medical Affairs, Technical Applications, Quality, R&D, Technical Packaging, and US and Global counterparts) providing clear boundaries and constructive options that move the business forward for all brands and categories within Nestlé Health Science Canada, including Natural Health Products, Foods for Special Dietary Use, and Food.
- Execute reviews and approvals for flawless workflow in formula and label development during Innovation and Renovation projects, including compliance of: formulations, raw materials and finished products, labelling, and product communication including new claims assessments.
- Monitor the external (local regulations) and internal (Nestlé standards) environment for emerging issues, trends and opportunities that may impact the business and execute implementation of relevant changes in the market, working with cross-functional team members as needed.
- Be accountable for the strategy of regulatory submissions for licensing and health authority engagements for new products, ingredients, claims or regulatory amendments as co-created with cross-functional team members. Assess responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and/or positive assessments.
- Support regulatory strategic engagements with Health Canada directly or through industry associations.
- Act as a Subject Matter Expert on assigned Regulatory projects and topics relevant to the success of the company, such as competitive compliance opportunities or deployment of new systems/tools.
Role Requirements
- Expert knowledge of Food and Drugs Act, Food and Drugs Regulations and Regulatory Affairs in both policy and technical practice for Natural Health Products (NHPs).
- Experience in building and implementing strategy in particular area.
- Recognised leadership skills.
- University degree in Science or related discipline. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets.
- Minimum 5 years' progressive experience in Regulatory Affairs within highly regulated categories (NHP, OTC, FSDU, etc).
- Exceptional organizational & efficiency skills – ability to organize work, multi-task, create detailed plans, monitor progress, follow-up and meet deadlines.
- Excellent oral and written communication and interpersonal skills, with superior attention to detail.
Preferred Skills
- Knowledge of and/or experience in the scientific, clinical and regulatory context of product development, commercialization, and marketing of natural health products 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-Recipe Management).
- Experience in building and implementing strategy in particular area.
What you need to know
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.
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