Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
-
Qualifications / Skills Required
1) BS in Food Science, Life Sciences or similar (preferred)
2) Graduate degree in Regulatory Affairs (preferred)
3) Master?s degree (preferred)
4) Minimum 5 years of related experience
5) Experience in database, spreadsheet and file management
6) Individual from natural organic food first, food second and pharma third preferred
7) Ability to navigate and solve problems in Navision software
8) Ability to multi-task and a team player
9) Highly detail-oriented with a strong desire to work with variety of information
10) Strong communication skills with the ability to communicate programs and policies thoroughly
11) Efficient data entry and database management skills
12) Great deal of flexibility and time management skills
13) Intermediate Excel skills
14) Strong organization skills
Job Description
Print Job Description
Partial Job Description 1) Manage the various projects involved with QA/QC and regulatory compliance 2) Ensure labeling systems administrator which includes master file management and label proofing 3) Manage project as assigned and prioritized by Director QA/QC and Regulatory Compliance 4) Manage state and federal applications, licenses and regulatory documents 5) Ensure labeling which includes reviewing and authorizing all labeling for compliance content 6) Ensure all FDA, FTC and USDA correspondence, including Structure Function Claims, NDIs and NOP certification 7) Create new regulatory sheets for new products and request documents for new product launches 8) Manage version control 9) Create new product substantiation binders 10) Manage change control file and database 11) Ensure GMPs system, process validations and FDA protocol 12) Prepare SOPs for distribution and finalize RDLs for use 13) Review and approve website updates 14) Perform other special project duties as assigned
