Zentis is Europe's number one fruit processing company and one of the leading brand manufacturers of jams, sweets and custard-based dessert. The Company's North American operations are located in Philadelphia, Pennsylvania and Plymouth, Indiana, where we produce fruit and dairy preparations for a variety of customers including yogurt, ice cream and bakery manufacturers.
The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance.
Primary Responsibilities:
Generate preliminary and commercial finished product specifications for dairy, bakery, ice cream and other preparations which include allergen and nutritional data and ingredient statements.
Collaborate with cross-functional teams and co-workers from Sales, Purchasing, QA and R&D to move projects to completion and launch on time.
Respond to customers’ finished product questionnaires and food safety surveys and provide certifications as needed for Zentis customers.
Prepare and submit legal export documentation for certificates.
Support regulatory, internal, customer, and third-party audits, such as SQF, HACCP, food safety initiatives, GMP audits, FSMA evaluations and plant safety team activities.
Represent the Regulatory Affairs function internally to improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.
Submit and maintain identity preserved processes for; Kosher, Non-GMO, HALAL, Organic, Gluten-free, Vegan and Natural.
Respond to internal customer requests for nutritional information and external consumers for allergenic content.
Maintain customer databases with specifications and supporting documentation; maintain internal ingredient databases including nutritional values, allergen status and other critical data.
Formal Education Required:
B.S. Food Science, Nutrition, or related discipline preferred.
Specific Experience and Key Knowledge Requirements:
Food industry experience in a technical role – 2-5 years
Experience reviewing and preparing regulatory documents such as labeling, customer specifications and certification submissions for a food manufacturer – 2 years minimum.
Hands-on experience reviewing product formulations and ingredients for inclusion in USDA Organic program, or for Kosher, Halal or Non-GMO certifications – 2 years minimum.
Experience working in a cross-functional project environment as a team member – 2 years minimum.
Food processing experience - plus factor.
Coursework or training in food labeling, US food regulations or similar - plus factor.
Project management training and/or experience - plus factor.
Special Skills and Abilities Required:
Positive, can-do attitude inclined to find solutions to complex regulatory questions.
Experience preparing accurate regulatory documents with a minimum of supervision.
Working knowledge of US labeling requirements including the naming of ingredients and nutrition facts labeling.
Strong verbal and written communication skills; experience presenting technical information to non-technical groups.
Proficiency with Microsoft Office365 applications needed to prepare, maintain and track documents, especially Excel and Word, PowerPoint; knowledge of SharePoint a plus.
Strong organizational and prioritization skills.
Ability to work quickly with accuracy and independently with a minimum of supervision.
EOE/M/F/H/V