Regulatory and Compliance Manager

Job Title: Regulatory and Compliance Manager

SUMMARY:

Nutrix International LLC is a small-business contract manufacturer specializing in oral care products. We formulate and manufacture cosmetic, over the counter (OTC) drugs, foods, and animal products for clients. The Regulatory and Compliance Manager oversees regulatory affairs and ensures full compliance with applicable laws, regulations, and industry standards in a dynamic contract manufacturing environment. The ideal candidate will be the primary liaison with regulatory bodies and clients, ensuring that all products meet necessary requirements from development to market release. This role is fully in-office, Monday through Friday, 8 am to 5 pm.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Regulatory Oversight:
• Interpret and implement applicable regulatory and quality standards (e.g., FDA, cGMP, ISO, HACCP, etc.).
• Have a working knowledge of FDA’s 21 CFR 110, 117, 210, 211, 507 and 700 regulations.
• Maintain up-to-date knowledge of relevant regulations across target markets (e.g., US, EU, Canada).
• Lead and coordinate regulatory projects and client audits.
• Compliance Management:
• Develop, maintain, and enforce internal policies and SOPs to ensure compliance.
• Conduct internal audits and coordinate third-party audits.
• Investigate and resolve compliance deviations and implement corrective and preventive actions (CAPAs).
• Manage and work alongside current Regulatory personnel to grow and strengthen the team.
• Documentation & Recordkeeping:
• Oversee the preparation and maintenance of regulatory documentation, such as master files, registration dossiers, and product specifications.
• Ensure accurate and timely documentation of manufacturing processes and changes.
• Cross-functional Collaboration:
• Partners with R&D, Quality, Sales, and Operations teams to ensure regulatory considerations are embedded early in the product development lifecycle.
• Serve as the primary regulatory contact for clients and external stakeholders.
• Training & Development:
• Conduct training sessions on regulatory and compliance requirements for internal teams.
• Promote a culture of quality and compliance across the organization.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy); Master’s preferred.
• 5+ years of regulatory or compliance experience in a contract manufacturing environment.
• Strong knowledge of relevant regulations (e.g., FDA 21 CFR, EU MDR, cGMP).
• Proven experience managing audits and regulatory inspections.
• Experience in team management and/or previous leadership role.
• Excellent analytical, organizational, and communication skills.
• Ability to multitask in a fast-paced, client-facing environment.

COMMUNICATIONS/LANGUAGE SKILLS:

· Proactive high-impact communication with all customers and internal employees

· Excellent written, verbal, and interpersonal skills

ABILITY TO MANAGE:

· Ability to demonstrate a high level of managerial and leadership skills

OTHER QUALIFICATIONS AND ABILITIES:

• Familiarity with multiple product categories (e.g., pharmaceuticals, OTCs, human and animal foods). Dietary supplements, medical devices, ANDA/NDA submissions preferred.
• Experience with regulatory-related submissions, license requirements, and technical file interpretations from vendor and laboratories.
• Regulatory Affairs Certification (RAC), Regulatory Affairs Professional Society Member (RAPS), or similar credential.

PHYSICAL DEMANDS:

· Field work may require considerable agility, bending and stretching

WORK ENVIRONMENT:

· This role is fully in-office, Monday-Friday 8 am to 5 pm.

· Work may require travel outside of the immediate region

Job Type: Full-time

Pay: $90,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Ability to Commute:

• Salt Lake City, UT 84116 (Required)

Ability to Relocate:

• Salt Lake City, UT 84116: Relocate before starting work (Required)

Work Location: In person