🌎
This job posting isn't available in all website languages
📁
Professional Sciences
📅
210002HI Requisition #

Senior Scientific & Regulatory Manager I

Intertek Scientific and Regulatory Consultancy Group is looking for a motivated and client focused regulatory affairs professional to support our food, nutrition and regulatory consulting services.  The Senior Scientific & Regulatory Manager 1 will 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 combines knowledge of regulatory affairs with an understanding of toxicology and general risk assessment practices for food ingredients/additives.  The Senior Scientific & Regulatory Manager 1 will support senior managers and guide junior staff as the team delivers innovative and bespoke assurance expertise mainly related to matters that are the subject of FDA oversight; however, general knowledge of European Union, Canadian, Australia/New Zealand and other global regulatory jurisdictions are an asset.  In this exciting role, the candidate will utilize their science background and general knowledge of these regulatory programs; develop their project and submission management experience; work with a team of experienced regulatory affairs/submission subject matter experts; and become a valued partner for our clients in the food and supplements industry.

Responsibilities:

  • Utilize, in daily work, experience with and understanding of regulations, regulatory processes, as well as understanding of how federal regulatory agencies interpret and apply the regulations.
  • Decide in detail the approach needed to resolve problems, e.g., previous knowledge regarding the problem type and applicable standards; decide generally how research is to be conducted, e.g., types of study that will be relevant/not relevant.
  • Review and interpret published/unpublished scientific materials, at first as individual studies/reports but finally in relation to each other. 
  • Support projects managed by others and perform assigned tasks needed to complete the project, subject only to occasional review by the Senior Scientist.
  • 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.
  • 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. 
  • Communicate with client as needed, requesting information or explaining the planned course of action.
  • Support development of junior staff: ensure toxicologists review research papers carefully to extract both metabolic and strict toxicity information as well as to identify any other potential avenues of research; review work of toxicologists, assisting them to assess risks; and help toxicologists develop scientific writing skills.

Desired qualifications:

  • Ph.D. (toxicology, nutrition, cellular or molecular biology, fermentation science, or related regulatory science) and 3 to 5 years of experience, M.Sc. (toxicology or related discipline) with 5 to 7 years of experience, B.Sc. (Toxicology) with 7 to 10 years experience.
  • Developed scientific expertise in the understanding and interpretation of most standard studies within the overall field of toxicology.
  • Subject matter expertise in FDA food safety frameworks.
  • Demonstrable success in designing and implementing evidence-based risk assessment frameworks for food ingredient safety evaluation.
  • 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/or dietary supplement ingredient notifications.

Personal characteristics:

  • Excellent customer service skills
  • Excellent communication skills in both verbal and written format
  • Excellent organization and time management skills
  • Effective business writing and composition skills with a good command of the English language
  • Ability to analyze and solve problems
  • Ability to work independently in a fast-paced, multi-tasking environment
  • Microsoft Office software expertise
  • Ability to work remotely (home based) or in an office in Mississauga, Ontario, Canada.

Similar Listings

Mississauga, Ontario, Canada

📁 Professional Sciences

Mississauga, Ontario, Canada

📁 Professional Sciences

Mississauga, Ontario, Canada

📁 Professional Sciences