Principal Regulatory Affairs Scientist

Kerry Group • Wisconsin Rapids, WI

19h

About The Position

The Principal Regulatory Affairs Scientist will join a team supporting Kerry’s Health Ingredients Portfolio, primarily focusing on biotics, botanical extracts, and nutritional lipids. This role encompasses a global framework with a specific emphasis on North American Regulatory Affairs strategies, primarily for Dietary Supplements, as well as Pharma, Clinical Infant and Adult Nutrition, and Pet Care. The position is centred on supporting innovation, strategic positioning, claims development, and customer-facing documentation, along with active involvement in trade associations.
We are seeking a highly motivated individual who can prioritize effectively in a dynamic and fast-paced environment. This role requires a strong team player with technical expertise, leadership capabilities, stakeholder management skills, and customer focus to help deliver forecasted revenue targets and support the development of a robust pipeline.

Requirements

• Master’s degree in Biological Science, Food Science, Chemistry, Biochemistry, Nutrition, or a related science field
• 7+ years’ experience in regulatory role(s) within the food industry, with specific focus on US law as minimum
• Previous composition and submission of GRAS or NDI notification to the US FDA.
• Previous composition and submission of a Master File to Health Canada NNHPD.
• Excellent writing skills with an aptitude to build a narrative based on scientific data.
• Excellent interpersonal and communication skills with ability to work within a team and independently.
• Knowledge of DSHEA and NNHPD regulatory landscape.
• Strong risk assessment, communication and stakeholder management skills
• Experience and proficiency with Microsoft programs, SAP, Optiva

Nice To Haves

• Previous experience with probiotics, botanicals, and lipids as dietary ingredients and natural health products.

Responsibilities

• Provide regulatory support with focus on Kerry’s Health Ingredient portfolio, including topics of Pro- and Post-Biotics, Botanical Extracts, and Nutritional Lipids.
• Execute compliance-focused efforts, such as GRAS notifications, New Dietary Ingredient notifications, Master Files, Product License Applications in partnership with relevant internal functions.
• Partnership with Medical Affairs, Marketing, RDA, Business Development, Product Managers, and Sales to help building and optimizing product positioning based on safety, pre-clinical and clinical data, to address gaps in data and product information.
• Collaborate with key functions across Kerry Health to align in positioning and build scientific-focused messaging and communications.
• Utilize the Kerry systems to review and update specifications and maintain familiarity with product lifecycle management.
• Participate in external conferences and trade associations as needed; scan and understand evolving government regulatory initiatives and requirements.

Benefits

• In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level