Regulatory Affairs Manager found on Intertek Health Sciences Inc

Regulatory Affairs Manager

Intertek Scientific and Regulatory Consultancy Group is looking for a motivated and client focused regulatory affairs professional who is seeking an opportunity to support our food, nutrition and regulatory consulting services. The Regulatory Affairs Manager 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 Regulatory Affairs Manager 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.
• eview and interpret published/unpublished scientific materials, at first as individual studies/reports but finally in relation to each other.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.

Qualifications

Desired qualifications:

• Ph.D. (toxicology, nutrition, cellular or molecular biology, fermentation science, or related regulatory science) and 1 to 2 years of experience, M.Sc. (toxicology or related discipline) with 3 to 5 years of experience, B.Sc. (Toxicology) with 5 to 8 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.

• 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
• Ability to pay attention to detail
• Ability to type quickly and accurately
• Microsoft Office software expertise

Intertek Canada offers a salary and benefit package competitively placed with the local market. We promote a culture where motivated customer-oriented employees can flourish, experience professional fulfillment and reach their highest potential. Medical, Prescription, Dental, Vision, and Disability Insurance plans; RRSP plan with company match; paid time off (vacation; sick holiday); Employee Assistance Program (EAP); Tuition Reimbursement, and more.

Please contact hr.canada@intertek.com if you need accommodation at any stage of the application process or want more information on our accommodation policies.