Regulatory Affairs Manager, Nutraceuticals

Regulatory Affairs Manager, Nutraceuticals

This position will carry out scientific, technology, and regulatory functions within Marlyn’s Quality Department. The Regulatory Affairs Manager will work closely with Marlyn’s Product Development, Business Development, Manufacturing, Packaging, QC and QA departments. Therefore, the Regulatory Affairs Manager must possess the necessary skills and abilities, required to accurately create and implement cGMP documents prior to launch of new and reformulated products.

To be considered, you must have the following knowledge, skills and abilities:

• A working knowledge FDA cGMP [21 CFR 111] and FDA labeling regulations [21 CFR 101.9 and 101.36] for dietary supplements
• Experience and ability to review dietary supplement master formulas of new and/or reformulated products. Based on this information, calculate nutritional values, review allergen analysis, and prepare supplement facts information sheets. Collect literature and data to substantiate labeling claims.
• Experience and ability to review labeling to ensure compliance to FDA labeling regulations, including supplement facts, principle display panel, and information panel.

Duties and Responsibilities:

• Responsible to write raw material, packaging, and finished product specifications. Specifications define the prerequisite conditions for the purchase of materials AND for QC testing.
• Prepare stability protocols, interim stability reports, and final stability reports.
• Prepare custom master case labels.
• Check work for accuracy before completion of tasks.
• Work, interact and communicate closely with Product Development department, QC manager , as well as Marlyn’s suppliers and clients.
• Other day to day activities include reviewing, correcting, updating, or creating Quality Master Documents, analyzing data, preparing change control documents, and generating reports.
• The ability and willingness to teach, interact, and convey information to other employees as well as to customers are essential.

Skills Required:

• Working knowledge of dietary ingredients and corresponding analytical test methods. Must be well versed in QC laboratory testing (analytical and microbiological) and QA systems.
• A working understanding of stability testing programs.
• Has the ability to follow and learn written procedures and verbal instructions. Critical thinking, time management, decision making and problem-solving skills are also necessary for this position.
• Strong chemistry, math, and computer skills background.

Experience Requirements:

• Minimum of 5 years of experience working in nutraceutical or pharmaceutical industry.
• Minimum of 2 years of experience working in a solid dosage (tablet, capsule, powders) manufacturing and packaging environment.
• Minimum of 2 years of experience working in QC or QA department.

Education Requirements:

• Minimum BS in Chemistry or related science.