Director, Regulatory Affairs

BestCo LLC; Mooresville (NC); On-site; USD 180,000 - 250,000; Full time

Job summary

BestCo LLC, a Crescendo Health division, seeks a Regulatory Affairs Director to lead a regulatory team and shape strategy ensuring FDA and Health Canada compliance for VMS and OTC products. You will collaborate with Quality, senior leadership, and cross-functional teams to align regulatory planning with business goals.

The role emphasizes developing robust documentation, managing SOPs, and maintaining regulatory archives while driving timely filings and risk mitigation.

Qualifications

• Bachelor's degree in law, business administration, food science or related field.
• 12 years of professional experience in regulatory compliance and/or quality assurance.
• 10 years of progressive supervisory/management experience.
• 3 years of OTC and/or pharmaceutical industry experience including FDA and Health Canada policies and procedures.
• Strong knowledge of drug cGMP and FDA requirements.
• Ability to lead with a high commitment to team values.
• Ability to communicate effectively with internal staff and management.
• Excellent problem-solving and analytical skills.

Responsibilities

• Lead regulatory strategy and ensure regulatory compliance for new product innovations and updates.
• Oversee regulatory labeling assessments and related communications with health authorities.
• Maintain documentation systems and SOPs in the Regulatory area.
• Collaborate with Quality, site leadership, and Senior Leadership to achieve business goals.
• Maintain regulatory archives and oversee filings to authorities (FDA, Health Canada).

Skills

Regulatory leadership

Regulatory compliance

cGMP knowledge

FDA regulations

Health Canada policies

Strategic thinking

Cross-functional collaboration

MS Office

Education

Bachelor's degree in law, business, food science or related field

Tools

Microsoft Office

Job description

We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices. With unique food science expertise and proprietary processes, we’ve pioneered many firsts. Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula!

The Regulatory Affairs Director leads a regulatory team and is responsible for ensuring the company is at the forefront of industry regulatory understanding. This position creates and drives regulatory strategy and ensures regulatory compliance. The Regulatory Affairs Director oversees the regulatory aspects of new product innovation, existing product changes or updates, and assures products and services are planned and implemented in a manner compliant with FDA, third party endorsements, and other applicable regulatory requirements. As a member of the leadership team, the Regulatory Affairs Director closely partners with Quality, collaborates with cross functional teams, site leadership, and members of the Senior Leadership Team to ensure successful attainment of all business goals and objectives.

Essential Duties and Responsibilities

• Partner with cross functional partners to drive more efficient and robust processes whilst maintaining the agility needed to succeed (e.g., claims support, raw materials qualification, etc.).
• Oversee regulatory compliance assessments of new and revised product labeling as well as any related communication with health and regulatory authorities.
• Drive and maintain structure function claim documentation and improve internal tools and databases to support product labeling claims.
• Identify legal risks regarding product labels, provide risk management and mitigation plans, and communicate this information to sales and marketing, as well as senior leadership, as needed.
• Provide regulatory input and feasibility assessments for new product development efforts by proactively gathering relevant information and/or justification.
• Create regulatory systems and processes. Implement and maintain a robust document management system.
• Oversee the development, improvement, and maintenance of Standard Operating Procedures (SOPs) related to the Regulatory functional area. As needed, review and contribute to cross functional SOPs.
• Establish and maintain regulatory archives in compliance with applicable regulatory requirements.
• Collaborate with other departments and senior management to develop sound quality agreements, product dossiers, and label agreements.
• Oversee all filings to regulatory authorities (e.g., site licensing for Health Canada, biannual FDA registration, etc.).
• Maintain knowledge of current applicable regulatory requirements including current Good Manufacturing Practice (cGMP), 21CFR:210, 211 and translate these requirements into Company policies and procedures.
• Maintain professional and technical knowledge by attending education workshops and reviewing professional publications.
• Provide insight and guidance on emerging regulatory opportunities and challenges.

The position carries out People Leader Responsibilities in accordance with the Company’s policies and applicable laws. Responsibilities include:

• Direct or indirect supervision of staff to include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and administering corrective actions; and addressing complaints and resolving problems.
• Manage, mentor, and coach direct reports including hiring, performance management, and professional development. Ensure continuous development of the Regulatory team.
• Ensure the safety and quality standards expected of all SCN BestCo staff are met.

Required Qualifications

Education & Experience:

• Bachelor’s degree in law, business administration, food science or related field.
• 12 years’ professional experience in regulatory compliance and/or quality assurance.
• 10 years’ progressive supervisory/manageme experience.
• 3 years’ OTC and/or pharmaceutical industry experience including FDA and Health Canada policies and procedures.
• Strong knowledge of drug cGMP and FDA requirements.
• Strong leadership, financial acumen, problem-solving, organizational development, attention to detail, judgment, and legal research skills.
• Ability to lead with a high commitment to team values.
• Proven business acumen, innovation, strategic thinking, professionalism, and visionary leadership skills.
• Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Outlook.
• Ability to apply complex mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to tasks such as frequency distribution, determining test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to routine inquiries or complaints from clients, regulatory bodies, or business community members. Ability to write speeches and articles for publication according to prescribed style and format. Ability to effectively present information to senior executives, management, public groups, and/or boards of directors.
• Must demonstrate practical problem-solving and troubleshooting skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and handle multiple abstract and concrete variables.

Preferred Qualifications

• Advanced degree in scientific or business administration.
• Quality assurance, quality control, regulatory compliance, and/or pharmaceutical manufacturing experience.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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