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Regulatory Affairs Manager

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Nestlé

1mo ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • North York
    Remote

AI generated summary

  • You need expert knowledge of NHP regulations, 5+ years in Regulatory Affairs, leadership skills, a relevant degree, and exceptional organization and communication abilities.
  • You will ensure compliance for NHP brands, drive regulatory strategies, collaborate cross-functionally, manage approvals for projects, monitor regulations, and engage with Health Canada.

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

Responsibilities

  • 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.
  • 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.

FAQs

What is the role of the Regulatory Affairs Manager at Nestlé Health Science Canada?

The Regulatory Affairs Manager provides strategic and functional regulatory leadership across the Canadian Nestlé Health Science business, ensuring that NHP brands are safe, compliant, and effective while collaborating with various functions to maximize patient and consumer outcomes.

What qualifications are required for this position?

Candidates should have a university degree in Science or a related discipline, with an advanced degree or post-graduate certification in Regulatory Affairs considered an asset. Additionally, a minimum of 5 years' progressive experience in Regulatory Affairs within highly regulated categories is required.

What specific knowledge is needed for this role?

Expert knowledge of the Food and Drugs Act, Food and Drugs Regulations, and regulatory affairs related to Natural Health Products (NHPs) is essential.

What are the preferred skills for this position?

Preferred skills include knowledge or experience in the scientific, clinical, and regulatory context of product development and commercialization of natural health products, as well as proficiency in Microsoft Office programs and an ability to learn technical databases quickly.

What responsibilities does the Regulatory Affairs Manager have in terms of regulatory submissions?

The Regulatory Affairs Manager will be accountable for the strategy of regulatory submissions for licensing and health authority engagements related to new products, ingredients, claims, or regulatory amendments and will assess responses to health authority requests.

Is there an opportunity for personal and professional growth in this role?

Yes, the company promotes personal growth through a people-focused culture and offers excellent training and development programs, as well as opportunities to grow within the organization.

What benefits are offered to employees?

Comprehensive benefits include health and dental coverage starting on day one, a company-matched pension plan, vacation time, personal paid holidays, flexible work arrangements, educational assistance, bonus eligibility, discounts on products, and more.

Is there a focus on diversity and inclusion within the company?

Yes, Nestlé Canada is an equal-opportunity employer committed to diversity, equity, inclusion, and accessibility, welcoming applicants from various backgrounds and experiences.

Will there be opportunities to engage directly with regulatory bodies?

Yes, the role involves supporting strategic engagements with Health Canada and working with industry associations.

Can employees work remotely?

Yes, remote work is supported in a hybrid format.

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Nestlé

Unlocking the power of food to enhance quality of life for everyone, today and for generations to come.

Retail & Consumer Goods
Industry
1-10
Employees

Mission & Purpose

As the world’s largest food and beverage company we are driven by a simple aim: unlocking the power of food to enhance quality of life for everyone, today and for generations to come. To deliver on this, we serve with passion, with a spirit of excellence, offering products and services for all stages of life, every moment of the day, helping people care for themselves and their families. Our culture is based on our values rooted in respect: respect for ourselves, respect for others, respect for diversity and respect for the future. We can trace our origin back to 1866, when the first European condensed milk factory was opened in Cham, Switzerland, by the Anglo-Swiss Condensed Milk Company. One year later, Henri Nestlé, a trained pharmacist, launched one of the world’s first prepared infant cereals ‘Farine lactée’ in Vevey, Switzerland. Today, we employ around 273,000 people and have factories or operations in almost every country in the world. With our headquarters still based in the Swiss town of Vevey, we had sales of CHF 84.3 billion in 2020. Our portfolio covers almost every food and beverage category –offering products and services for all stages of life, every moment of the day, helping people care for themselves and their families. House rules: https://nes.tl/HouseRules

Culture & Values

  • Respect for ourselves

    Respect starts with self-respect. Being true to ourselves, while acting with integrity, fairness and authenticity.

  • Respect for others

    Respecting others is about meeting our promises. It’s about quality in our products, our brands and everything we do.

  • Respect for diversity

    Respect for other ways of thinking, other cultures and all aspects of society requires inclusiveness and openness in all our interactions.

  • Respect for the future

    Respect for the future of our planet and future generations compels us to act with responsibility and courage, even if it’s difficult.

Benefits

  • Competitive remuneration

    You’ll be recognized for your contribution with a competitive salary and benefits package. And you may benefit from savings plans, insurances, loans, and discounted or free Nestlé products. You could even grab a bargain on retail products, services and activities.

  • Location-specific opportunities

    Our working environments vary greatly, so depending on your job and your location, you could benefit from flexible working opportunities, volunteering programs, the ability to bring a pet to work, and much more.

  • International mobility

    We offer opportunities to develop your career in different countries around the world. Global mobility plays an important part in developing Nestlé’s talent and our brands.

  • Health and wellbeing at work

    Our employee health programs will help you develop and maintain a healthy lifestyle, with health checks, health care, onsite cafeterias and fitness centres, sport and other activities.

  • Employee support

    More than ever, it is important that you are emotionally supported while at work and at home to be resilient and feel good as you carry out your everyday activities. We provide access to confidential counsellors to help when the unexpected happens or you are feeling overwhelmed.

  • Parental leave

    With a minimum of 18 weeks paid parental leave for the primary caregiver, plus the opportunity to take further leave, your new family life can get off to a great start. Your work location may provide additional benefits and resources such as dedicated feeding rooms or creches.