Senior Scientific and Regulatory Affairs Manager - Intertek USA Inc

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 Principal Scientist/Associate Director 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 incumbent 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.

How you will make an impact at Intertek:

• 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.
• Monitor and keep project team updated on regulatory developments pertinent to approvals of regulated ingredients including new or revised policies, guidance, and safety assessment approaches.
• 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, train, and further develop the food regulatory team, applying effective organizational and planning skills required in a multidisciplinary and matrixed environment.

Requirements:

• B.S., M.S., or Ph.D., regulatory science, risk assessment, toxicology, cellular or molecular biology, food biotechnology science, or combination thereof.
• 10+ years of experience working in the regulatory sciences within the food manufacturing or consulting industries. 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.
• Ability to solve complex scientific problems
• Strong time management and delegation skills to meet more complex project timelines.
• Able to work independently and lead teams.
• Strong stakeholder management skills.
• Ability to deliver financial objectives.
• Motivated to meet internal and external deadlines.
• Ability to work independently in a fast-paced, multi-tasking environment.

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 .

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.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

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#LI-RemoteIntertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.