SUMMARY
The Regulatory Specialist will coordinate the execution and timely completion of regulatory compliance tasks for the sale of New Sunshine products.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Obtain, maintain, and update all raw material documents needed for correct ingredient label copy and raw material specification.
Organize regulatory documents and communicate their location so they can be used by R&D, Production and Branding departments, as needed.
Collaboration with cross-functional teams including Regulatory, R&D, Quality, Branding, Creative, etc. in order to support and communicate project status and business priorities.
Working with the Regulatory Supervisor to develop execution plans for gaining or maintaining compliance. Works with confidential material on a daily basis and is required to maintain confidentiality at all times.
Create or obtain and maintain raw material information on D365 and in the appropriate R&D files, including, but not limited to SDS, specifications, technical information, blend information and cosmos international registration database.
Provide ingredient listing, review graphic and vendor label proofs and provide timely comments to Branding.
Develop working relationships with Retail Sales team and continue to maintain Retail Sales Tracker process and spreadsheet. Maintain WERCS registrations, processes and communications as needed.
Obtains translations for labels as needed and organizes translations data and checks translation information on labels.
Investigate technical and other raw material issues and follow up with raw material vendors as needed. Work with R&D chemists as needed when vendor issues arise.
Interface with R&D staff to stay up to date on project status and business priorities.
Maintain documentation of all pertinent information and communicate with co-workers as needed to help them utilize documentation
Stay abreast of regulatory requirements and changes in appropriate countries and develop execution plans for gaining or maintaining compliance.
Utilize spreadsheets to sort data, calculate formulas and manipulate other data as needed. Excel type experience preferred.
SUPERVISORY RESPONSIBILITIES
This job does not have supervisory responsibilities.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's degree (B.S) in Science discipline plus five years’ related experience and/or training; or equivalent combination of education and experience. Quality Assurance, GMP and other Compliance or Regulatory type experiences are a plus. Must have the ability to create, maintain and read computer generated files such as formulas, procedures, specifications, and ingredient label format. Ability to generate reporting from electronic data is also required in this position. Proficient in Microsoft works: Word, Excel, Outlook.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS:
GMP certifications or training are an advantage.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to sit; use hands or fingers, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to stand; walk; and smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus and differentiate shades of the same color.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually quiet.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
