Regulatory Strategy Director

SCN BestCo; Mooresville (NC); On-site; USD 170,000 - 250,000; Full time

Job summary

SCN BestCo in the United States seeks a Regulatory Affairs Director to lead a regulatory team and drive strategy for FDA, Health Canada and related authorities, ensuring product labeling, approvals and compliance across all stages of development.

You will partner with Quality, site leadership and senior management to align regulatory plans with business goals, oversee filings, SOPs and risk management, and mentor the regulatory staff to sustain robust governance and timely product launches.

Qualifications

• 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.

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.

Skills

Regulatory leadership

GxP knowledge

FDA knowledge

Policy development

Risk management

Education

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

Tools

Microsoft Office

Job description

SCN BestCo in the United States seeks a Regulatory Affairs Director to lead a regulatory team and drive strategy for FDA, Health Canada and related authorities, ensuring product labeling, approvals and compliance across all stages of development.

You will partner with Quality, site leadership and senior management to align regulatory plans with business goals, oversee filings, SOPs and risk management, and mentor the regulatory staff to sustain robust governance and timely product launches.