Director, Regulatory Affairs

SCN BestCo; North Carolina; On-site; USD 150,000 - 210,000; Full time

Job summary

SCN BestCo, a leading health products company, seeks a Regulatory Affairs Director to lead a regulatory team and shape regulatory strategy ensuring FDA and Health Canada compliance for VMS, OTC and probiotic products.

You will partner with Quality and cross-functional teams to drive compliant product innovation, labeling, and regulatory filings, while mentoring staff and aligning with senior leadership on business objectives.

Qualifications

• Bachelor’s degree in law, business administration, food science or related field.
• 12+ years in regulatory compliance and/or quality assurance.
• 10+ years supervisory/management experience.
• 3 years OTC/pharma industry experience including FDA and Health Canada policies.

Responsibilities

• Partner with cross-functional teams to drive robust processes while maintaining agility.
• Oversee regulatory labeling compliance and related communications with health authorities.
• Drive and maintain documentation for labeling claims and internal tools/databases.
• Identify legal risks, communicate mitigation plans to sales, marketing and leadership.
• Provide regulatory input for new product development and feasibility assessments.
• Create and maintain regulatory systems and document management processes.
• Oversee SOPs for Regulatory and contribute to cross-functional SOPs.
• Maintain regulatory archives in compliance with requirements.
• Collaborate with departments to develop dossiers and label agreements.
• Oversee filings to authorities (e.g., FDA registrations, Health Canada).
• Keep knowledge current on 505(c), cGMP, 21 CFR Parts 210,211; adapt policies accordingly.
• Maintain professional knowledge through education and publications; guide team.

Skills

Regulatory leadership

FDA compliance

Health Canada

Strategic regulatory planning

Cross-functional collaboration

Leadership and mentoring

Education

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

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 505c and translate these requirements into Company policies and procedures.
• 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.

People Leader Responsibilities

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/management experience.
• 3 years’ OTC and/or pharmaceutical industry experience including FDA and Health Canada policies and procedures.

Knowledge, Skills, & Abilities (KSAs):

• Strong knowledge of drug cGMP and FDA requirements.
• Strong leadership, communication, problem-solving, organizational development, analytical & presentation skills.
• Financial acumen, oral and written communication skills.
• Ability to lead with a high commitment to team values.
• Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Outlook.
• Proven business acumen, innovation, strategic thinking, professionalism, visionary leadership, and problem-solving skills.
• Strong attention to detail, judgment, legal research, written communication, and organizational skills.

Preferred Qualifications

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