COMPLIANCE AND REGULATORY SPECIALIST
Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers. Simply put - we make healthy gummies. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
Support the organization as a Subject Matter Expert (SME) in U.S. regulatory requirements, Nutrition Labelling and Education Act (NLEA), as well as internal risks related to Food Safety, across the organization. Also, responsible for the development of Catalent’s quality system at the Business Unit level and assists in the implementation at the local site level. This position is also responsible for supplier and raw material document review and approval and is a subject matter expert on SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.
STANDARD WORK HOURS: MONDAY-FRIDAY 8AM-5 PM
Regulatory and Food Safety Subject Matter Expert (SME) who provides feedback and guidance to internal and external customers.
Experience in US Regulatory requirements and familiar with the most common regulations for EU, Mexico and Canada.
Experience creating and reviewing technical and product regulatory documentation (technical data sheets, list of predominance, specifications, supplement facts panels, etc)
Nutrition Labeling and Education Act (NLEA) SME for food and dietary supplements.
Leads or support regulatory compliance review for marketing materials and labeling with Marketing, R&D and Sales.
Experience with Organic, Kosher, Halal product and facility certification
Support Product Risk Assessment tasks to ensure all Quality, Regulatory and Food Safety risks have been identified and clearly communicated to the organization and captured in the appropriate FSQA plans.
Partner with R&D to develop specifications, Master Formulas, Master Manufacturing Records and Batch Production Records that ensure the strength, quality, purity, and efficacy of manufactured products.
Partner with cross-functional teams to ensure successful launch of all current and new products by identifying food safety, quality and regulatory risks and counter measures to mitigate risks.
Other duties as assigned.
Bachelor’s degree in Science Field, Food Science preferred; Master’s Degree is a plus
Minimum 5 years of direct experience in dietary supplement, food, pharmaceutical, or FDA regulated industry; confectionary industry a plus.
Experience both developing and implementing quality programs and process improvement is preferred.
HACCP trained, SQF Practitioner and PCQI certified (or ability to become)
Ability to prioritize and follow-through to achieve results and meet deadlines.
Strong foundation in interpersonal communication concepts, specifically, written, oral, presentation, listening, and facilitation skills in English
The employee must be able to lift and/or move up to 30 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell.
CATALENT’S STANDARD LEADERSHIP COMPETENCIES
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
WHY YOU SHOULD JOIN CATALENT:
Diverse, inclusive culture
401(k) retirement savings plan with company match
19 days paid time off
Medical, dental, and vision insurance
Fitness center and wellness programs
Flexible spending account
Employee discount programs
Robust employee referral program
CATALENT OFFERS REWARDING OPPORTUNITIES TO FURTHER YOUR CAREER!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to firstname.lastname@example.org for us to investigate with local authorities.
Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.