Job Description

Marlyn Nutraceuticals is a 70-year-old leading dietary supplement manufacturer committed to adhering to strict Good Manufacturing Practices (GMP) and making decisions based on scientific principles and 21 CFR regulation. We believe that every department plays a critical role in operational excellence and compliance, and we are dedicated to producing high-quality products that prioritize consumer safety and the efficacy of our supplements for our customers. By combining cutting-edge manufacturing technology with unwavering quality standards, we create supplements that make a real difference in people's lives.

Our direct compression, solid-dose dietary supplements are designed to enhance wellness and improve quality of life. We utilize reduced direct compression processing and manufacturing methods to ensure the preservation of active ingredients and stability, allowing us to expand our customers' business offerings.

Role Summary

The Director of Regulatory Affairs and Quality Control is responsible for ensuring Marlyn's manufacturing, labeling, and marketing practices comply with all relevant regulations, including DSHEA, FDA, cGMP, and 21 CFR requirements for dietary supplements. This role collaborates closely with the Product Development (PD) and Quality Assurance (QA) departments to uphold the highest standards of regulatory product quality and safety across our company. Additionally, the Director oversees the work of our QC Manager and our in-house analytical laboratory (QC) staff.

Key Responsibilities

Regulatory Compliance:

• Ensure comprehensive compliance with DSHEA, FDA, FTC, and state regulations for dietary supplements manufacturing and marketing
• Oversee product labeling to accurately reflect ingredients, dosage, and health claims in adherence with FDA and FTC regulations
• Substantiate health claims made about Marlyn's supplements based on "competent and reliable scientific evidence" per FTC requirements
• Handle New Dietary Ingredient Notifications to the FDA
• Manage product registrations for domestic and foreign manufacturing

QC and QA Regulatory Review:

• Approve and monitor testing protocols of ingredients and finished products to verify purity and potency, preventing adulteration and contamination
• Ensure Marlyn's manufacturing facility and processes adhere to all applicable requirements, including quality control measures
• Approve and monitor stability study protocols to confirm product shelf life and integrity
• Evaluate and engage third-party testing and certification programs (e.g., NSF International, USP) to provide additional quality validation

PD Regulatory Review:

• Verify ingredient selections are compliant with all applicable regulations, customer requirements and that calculated correction factors align to required label claims labeled claims
• Approve formulas and master batch records to assure compliance with all applicable regulations

QC Department Oversight:

• Approve workload plans and staffing proposed by the QC Manager
• Provide support to the QC Manager regarding issues or challenges with test methods, protocols, deviations, OOSs or other related quality or staff concerns
• Drive continuous improvement of in-house testing and certifications
• Facilitate QC’s collaboration with Marlyn’s technical and business groups

Communication:

• Effectively communicate information about potential regulatory changes and any compliance issues to relevant stakeholders
• Provide regulatory guidance and input during new product development to ensure feasibility of meeting regulatory and customer standards
• Lead Marlyn’s technical and quality discussions with our contract customers

Required Qualifications & Skills

• Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Quality Assurance, Pharmaceutical Sciences)
• Minimum 5 years of experience in regulatory affairs and quality control within the dietary supplement or pharmaceutical industry
• In-depth and strong understanding and knowledge of DSHEA, FDA cGMP regulations, 21 CFR, and other relevant laws and guidelines
• Strong analytical and problem-solving skills
• Excellent written and verbal communication abilities
• Familiarity with Lean Thinking and Practices to drive and embrace continuous improvement

Marlyn's 100-member strong team is committed to fostering a collaborative, lean-driven environment focused on eliminating waste, improving processes, and delivering exceptional value to our customers. The Director of Regulatory Affairs and Quality Control will play a vital role in upholding these principles and ensuring the quality and compliance of our dietary supplement products.  We passionately believe in equality for everyone, regardless of age, sex, sexual orientation, race, color, creed, religion, ethnicity, national origin, disability, military or veteran status, or any other legally recognized protected basis under federal, state or local laws, regulations or ordinances.

We Offer

* Competitive salary and comprehensive benefits package

* Health, dental, and vision coverage for you and your family

* 401(k) retirement plan with company match

* Paid holidays, vacation, and sick time

* Year-end performance bonus

* Professional development opportunities

* Inclusive work environment committed to equality and diversity

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