The Regulatory Affairs Manager monitors regulations and certifications applicable to The Synergy Company operations and ensures compliance according to internal policies, regulatory agencies and legal standards. This position is responsible for implementation of all regulations related to labeling and for managing Synergy Organic/Non-GMO, and Kosher certificates.
Stays current with regulations including, but not limited to, Bioterrorism Act, FSMA, cGMPs, Kosher, Non-GMO, Canadian NHP, JAS, and NOP. Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the company's product development program.
Reviews and provides legal and regulatory risk analysis for Marketing material. Must be willing to adapt to ever-changing marketing strategies and media formats with quick review and reporting/discussions. For example:
Customer Education literature
Ads-Web, E-Mail, Magazines etc.
Social Media (Twitter, Facebook, etc)
Amazon Seller and Product Descriptions
Reviews all Synergy Company product labels to satisfy regulatory requirements. This includes management of the label design process and communications with graphic artist. Submits and reviews labels with certifying bodies as required.
Maintains organic and kosher compliance as well as managing certification agencies to meet Synergy’s needs.
Ensures that appropriate, up-to-date records are maintained for compliance.
Facilitate external audits with regulatory agencies.
Performs internal regulatory audits and reports findings to Director of Quality and COO.
Researches and advises on regulatory requirements for product export or import.
Communicate regulatory and certification requirements with appropriate managers and departments. Responds to the various changes in regulatory requirements and collaborates with affected department managers.
Reviews company procedures and advises of necessary change according to legal, regulatory and certification requirements.
Reviews distributors’ US labels for US regulatory compliance and Synergy standards. Submits and reviews labels with certifying bodies when appropriate. Reviews foreign distributor labels for Synergy compliance.
Facilitates annual Organic and GMP training for all employees. Responsible to evaluate and implement other training programs concerning regulations or certifications.
Conducts and compiles research to assist in the development of material and product specifications.
Manages documentation to support the Sales and Marketing Claims.
Reviews formulas, formula changes, and evaluates these with the current manufacturing batch records for consistency. Checks formulas against labels.
Identifies potential regulatory risks to the operational plans, and proposes options to mitigate risks.
Coordinates and prepares document packages for regulatory submissions.
Maintains electronic system organization related to regulatory documentation and tracking. This includes, but is not limited to the ERP system and Network Folder management.
Reports to Director and Executive management on current regulatory industry concerns and upcoming regulations and governmental/certifier expectations that would affect import and exports of products and goods, labeling, marketing, manufacturing, or any other aspects within the company that would need to change or be assessed.
Knowledge and Skills Desired:
Ability to multitask. Handle large email volume and multiple priorities daily. Ability maintain composure in a high pace environment.
Ability to effectively interact with coworkers, suppliers and customers.
Ability to analyze, evaluate and reason with information and data to make decisions and solve problems concerning quality.
Ability to obtain information from diverse sources and then synthesize and organize this information to determine, implement and monitor cohesive and comprehensive plans and systems. As well as effectively communicate the information to management with simplicity for easy understanding or clearly outlined for action potential action items.
Ability to evaluate information against a set of standards and verify its accuracy.
Ability to effectively communicate with others in written and verbal forms.
Skills in conflict management and diplomacy.
Ability to use a computer and software associated with the position.
Ability to analyze, interpret and appropriately apply industry legal and regulatory directives including FDA, USDA and FCC policies.
Ability to manage external audits and perform internal audits.
Understanding of the importance of Continuous Improvement as well as root cause analysis.
Knowledge sharing – being the educator for the company.
Internal Number: RAM
About The Synergy Company
MADE IN MOAB
We are situated in the beautiful community of Moab, Utah, inspired by the red rock canyons and breathtaking La Sal Mountains surrounding us.
We have been privately and family owned and operated since our official launch in 1992 — a tight knit family of employees involved in every aspect of our mission. While our company continues to grow every day, we never have and never will compromise our small company and family values. Our customers rave about our products and our personal, in-house customer service team. Our personal relationship with you is one of our most important goals.
From its modest beginnings in a home office with just a few visionary employees, our company has expanded into a world-renowned, award-winning, certified organic facility with 75+ dedicated employees from all walks of life. The common denominator among us is our desire to be a part of a company that truly makes a difference.
OUR AWARD-WINNING FACILITIES
*Third-party certified to manufacture USDA organic and kosher products,
*FDA registered, GMP compliant,
*Fully climate controlled,
*State-of-the-art air and water filtration,
*Oxygen-free, moisture-free Ultra Fresh Packaging,
*Refrigerated storage for all of our ingredients,
*100% wind-powered operations, and
Internationally compliant, quality assurance program with in-house laboratory.