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Scientific and Regulatory Manager at Intertek USA Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: LOWELL, Massachusetts





Job Description:

Description

What are we looking for?

Intertek Scientific and Regulatory Consultancy Group is actively seeking a Scientific and Regulatory Manager to support our food, nutrition, and regulatory consutling services. The ideal Scientific and Regulatory Manager candidate will be highly motivated and client focused in toxicology and regulatory affairs. The Scientific and Regulatory 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 Scientific and Regulatory 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.

How you will make an impact at Intertek Scientific and Regulatory Consultancy Group:


  • 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  • eview and interpret published/unpublished scientific materials, at first as individual studies/reports but finally in relation to each other.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

What it takes to be successful in this role:


  • 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.

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
  • Ability to pay attention to detail
  • Microsoft Office software expertise

Why work at Intertek?
Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about Our History and What We Do .

Intertek is committed to a safe work environment for our employees and clients. Learn more about our COVID-19 Policy .

What we have to offer:
When Working with Intertek , you can expect salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.

Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test.

Intertek believes that Our People are our strongest tool for success. We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.

For individuals with disabilities who would like to request an accommodation, or who need assistance applying, please email hr.eeoc.data@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department

CA-TB





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