Sr Manager, Regulatory Affairs & Compliance (Nutraceuticals)
Company: Keystone & Golden, Inc.
Posted on: September 21, 2022
Our Client is an industry leading distributor of nutritional
supplements offered in both the DTC and Practitioner Channels. The
Company has recently acquired four brands and has a unique growth
strategy focused on condition specific health solutions and a
commitment to consumer centric needs. The products are category
leaders in specific channels and experiencing significant growth
over the last several years. By providing comprehensive support
through their line of over 300 products, ongoing clinical
education, and practice development programs, they help maximize
the potential for successful health outcomes.
This is a fully remote position
This individual will be responsible for managing and coordinating
implementation of all regulatory and quality management systems
requirements across all brands reflective of both the FDA CFR
section 111 and the Company's policies and practices. This
coordination includes making sure the Company is fully compliant
and meeting all requirements for product registrations (dietary
supplements and medical devices), product label reviews and
approvals, confirmation of ingredient status (i.e., GRAS, NDI) of
raw materials used in products claims review in all customer facing
materials and content (labels, marketing collateral, websites and
presentations) along with managing substantiation support and
documentation for these claims. Management of cGMP Quality systems
(i.e., SOP's, SOP Training, Adverse Events Reporting, Document
Control) for full integration across all Brands is a critical
responsibility of the position Coordination of the regulatory
review process and cGMP standards across a multi-disciplinary team
is an integral role to maintain regulatory compliance and a
demonstration of the Company's full commitment to users of the
company product portfolio.
- Oversight for coordination and execution of regulatory
requirements and procedures, ensuring full compliance across all
brands of the Company
- Management coordination of regulatory review of product
information including technical specification issues,
marketing/sales literature, labeling and advertising materials. As
a member of a cross functional review team, provide revisions to
copy and claims that will be compliant.
- Oversee the customer inquiries by distributing questions and/or
coordinating with other personnel for timely responses to customer
- Monitors competitive claims, FDA's and FTC's actions,
litigation, news releases and other sources, as they relate to the
current science of company-related products and challenges to
prevent product claims, to ensure that company limits its exposure
for product claims
- Assist in the evaluation and monitoring of domestic contract
- Work with Quality Control Teams as defined under SOP
requirements to help maintain label systems, create and maintain
product labels while working closely the assigned cross-functional
team responsible for label copy and reviews.
- Work with marketing teams in for label compliance and
compliance reviews of all website content.
- Work with the Product Portfolio Team on all new product
launches and relaunches to ensure full compliance
- Assist and support in the process of customer and government
regulated internal audits along with the requirements for NSF
Certification audit and maintaining that designation for cGMP
- As appropriate, suggest areas of improvement for system
management and/or processes and make recommendations for
- Provide reports and other information as required for
Management review of Quality/Regulatory Systems and/or NSF
Certification to ensure full compliance as defined by the FDA and
NSF cGMP requirements.
- Ensure Quality Systems Management processes are in place across
all brands and coordinated for consistency across all under the
- Liaise internally with members of the company's functional
- Master's degree in a scientific field is required with emphasis
on regulatory affairs and Quality Assurance cGMP requirements in
the dietary supplements category a plus.
- Direct experience with regulatory compliance requirements for
foods,dietary supplement and or medical device products..
- Five to seven years of experience in a regulatory role having
oversite to compliance and involvement in QMS. Experience with NSF
Certification requirements a plus.
- Direct experience with ingredient line generation for dietary
supplements and/or nutrition facts panels, and product labeling -
claims requirements in the United States. Some knowledge and
experience of Canadian regulatory requirements would be
- Ability to develop and review substantiate claims documentation
(Structure function, Nutrient content, Dietary supplement, etc.)
and effectively communicate regulatory stance on such claims to
internal and external customers.
- Knowledge and experience of California Prop 65
- Specific experience and knowledge of dietary supplements cGMP
- Knowledge and experience of international regulatory
requirements and submissions, including awareness of eCommerce
- Knowledge and experience with adverse events reporting and
- Experience in SOP Training for all teams of the company.
Formal certification for any specific regulatory compliance
practice is a plus.
Benefits include medical insurance, company-funded Health
Reimbursement Account, 401K plan with company-match and a generous
yearly allowance for company products for personal use (1000/year
and 300 wellness stipend)
Keywords: Keystone & Golden, Inc., Middletown , Sr Manager, Regulatory Affairs & Compliance (Nutraceuticals), Executive , Middletown, Connecticut
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