Regulatory Affairs Specialist

POSITION SUMMARY:

Responsible for all aspects of the documentation process including the label/supplement facts panel (SFP) development, review and implementation of dietary supplement labels for private label, branded and contract formulations, create internal Finished Product Specifications, etc. Furnish and support International Registration Documentation, Various Certification (Vegan, Organic, Non-GMO, etc.) Documentation, Customer specific forms and questionnaires and online portals.

ESSENTIAL FUNCTIONS:

• Preparation of all documentation included but not limited to (SFP, Finished product specs, label review, international documents, etc.)
• Coordinate the development of a Principle Display Panel (PDP) for private label, branded and contract dietary supplements
• Coordinate the development of an Information Panel (IP) for private label, branded and contract dietary supplements
• Accurately implement all relevant information that must appear on a specific SFP utilizing the correct SFP format according to regulatory guidelines.
• Facilitate the interdepartmental and customer (when applicable) approval of a draft SFP to ensure that a Purchase Order (PO) is placed in a timely manner.
• Develops a PDP and IP based on information provided by product development, marketing/sales and the customer (when appropriate) that accurately reflects the draft SFP
• Ensures the accurate transference of draft label information to ancillary packaging materials such as a box or packet in accordance with regulatory guidelines when applicable.
• Facilitates the interdepartmental and customer (when applicable) approval of a complete draft label (SFP, PDP and IP) and ancillary packaging material (when applicable) for submission to the Art Department for the development of a label proof.
• Coordinates the development of a label (and ancillary packaging) proof(s) with the Art Department for QC, Product Development and customer (when appropriate) approval.
• In the instance of Reliance private label products, coordinates the final label approval (after the new product launch) and setting of the new label to the Master File with the Art Department.
• Collect the necessary documentation in accordance with labeling requirements such as allergens, warnings and principle display panel information and information display panel.
• International registration documentation coordination.
• Assist in the maintenance of 3rd party certifications such as NSF, Organic, etc.
• Assist in transfer of Technology process.
• Managing Customer specific online portals.

REPORTING RELATIONSHIPS:

• Regulatory Affairs Supervisor
• Product Development & Regulatory Affairs Manager

Critical Operating Relationships:

• QA Manager
• QC Manager

QUALIFICATIONS:

Education:

• Bachelor’s degree in a science related field

Experience:

KNOWLEDGE, SKILLS AND ABILITIES:

• Conversant with regulatory guidelines (preferably dietary supplements regulations CFR 111)
• Understand and interpret FDA guidelines for nutritional labeling, rounding rules, percent daily values and other applicable technical/regulatory information
• Ability to read, understand and interpret technical documentation with a high degree of accuracy

• Proficiency with MS office, especially Word, Excel.
• Strong research skills, attention to detail, accuracy and precision. Highly organized. Strong verbal and written communication skills. Mathematically proficient.
• Able to proof read with a high degree of accuracy.
• Ability to interpret scientific research and disseminate information in an accurate and productive manner.

OPTIMAL EXPECTATIONS:

• Development of dietary supplement labels from inception to completion ensuring technical accuracy and compliance to all mandated regulatory requirements.
• Assist in the coordination of International Documentation and Any regulatory or 3rd party certification documentation.
• Managing various customer specific online portals.
• Assist in the transfer of technology Process