Compliance and Regulatory Specialist
Company: Catalent Pharma Solutions
Location: Green Bay
Posted on: June 24, 2022
**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
- 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
- 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
- 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
- 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
- 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
- Experience both developing and implementing quality programs and
process improvement is preferred.
- HACCP trained, SQF Practitioner and PCQI certified (or ability to
- Ability to prioritize and follow-through to achieve results and
- 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
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
**WHY YOU SHOULD JOIN CATALENT:**
- Diverse, inclusive culture
- Competitive salary
- 401(k) retirement savings plan with company match
- Educational assistance/reimbursement
- 19 days paid time off
- Medical, dental, and vision insurance
- Life insurance
- Fitness center and wellness programs
- Flexible spending account
- Employee discount programs
- Robust employee referral program
**CATALENT OFFERS REWARDING OPPORTUNITIES TO FURTHER YOUR
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
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
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
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
**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.
Keywords: Catalent Pharma Solutions, Green Bay , Compliance and Regulatory Specialist, Other , Green Bay, Wisconsin
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