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Professional Sciences
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210002HL Requisition #

Senior Regulatory Affairs Manager 2

Intertek Scientific and Regulatory Consultancy Group is looking for a motivated and client focused senior regulatory affairs professional who is seeking an opportunity to be a Program Manager to promote our food, nutrition and regulatory consulting services.  The Senior Regulatory Affairs Manager 2 will lead and guide our clients on matters related to food ingredient compliance, regulations, guidance, and applicable statutes related to food ingredient approvals on a global basis, with emphasis on the North American marketplace. This role necessarily combines knowledge of global regulatory affairs with a deep understanding of toxicology and general risk assessment practices for food ingredients/additives.  The Senior Regulatory Affairs Manager 2 will directly engage with and support Intertek’s clients serving as a representative of Intertek and a subject matter expert for the company primarily related to matters that are the subject of FDA oversight; however, general or extensive knowledge of European Union, Canadian, Australia/New Zealand and other global regulatory jurisdictions are an asset.  In this exciting role, the candidate will use their project and submission management experience; work with a team of experienced regulatory affairs/submission subject matter experts; and use their industry contacts to grow our consulting services.

Responsibilities:

  • Identify new target customers and new opportunities within existing customer base.
  • Establish and maintain regulatory relationships with key clients as well as internal and government stakeholders, to promote Intertek’s mission and values of total quality assurance and scientific excellence. 
  • Effectively utilize established network of contacts within the industry, including trade. associations, consultants and regulatory agency contacts, to identify and resolve regulatory issues and increase visibility to our expertise and services.
  • Act as key account contact, project manager, and author/reviewer of submission documents, utilizing strong track record of regulatory success bringing GRAS/novel food ingredients to the market on time and on budget.
  • Lead successful project teams, applying effective organizational and planning skills required in a multidisciplinary and matrixed environment.
  • Manage assigned projects: review basic project issues considering special expertise needed and assignment of staff; oversee the work of juniors in the team and guide them on the selection and use of associated scientific information; review work of toxicologists and support assessment of risk; ensure work is kept focused on client’s needs; and deliver project reports to client on time, on spec and on budget.
  • Act as senior leader for the team:  support leadership in meeting goals and objectives and contribute to development of junior staff.

Desired qualifications:

  • B.S., M.S., Ph.D., or JD in regulatory science, regulatory law or risk assessment, toxicology, cellular or molecular biology, fermentation science, or combination thereof.
  • 7-10 years of experience working in the regulatory sciences within the food manufacturing industry. Strong knowledge of the U.S. regulatory system required and general understanding of EU and Canadian regulatory systems desirable.
  • Strong networking skills.
  • Subject matter expertise in FDA food safety frameworks.
  • Demonstrable success in designing and implementing evidence-based risk assessment frameworks for food ingredient safety evaluation.
  • Extensive experience in sourcing and applying legal, regulatory, and policy precedents to novel food products.
  • Demonstrable success in assembling GRAS dossiers, EU/Canada novel food applications, food additive petitions, and dietary supplement ingredient notifications.
  • Demonstrable evidence of competency in coordinating and convening GRAS panels on an independent basis with limited oversight.

 

Personal characteristics

  • Excellent oral and written communication skills.
  • Well organized and structured (attention to detail).
  • Able to work independently and in teams.
  • Ability to deliver financial objectives.
  • Motivated to meet submission timelines.
  • Ability to work remotely (home based) or in an office in Mississauga, Ontario, Canada.

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