Regulatory Strategy Director & Compliance Lead

SCN BestCo; North Carolina; Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory leadership

FDA compliance

Health Canada

Strategic regulatory planning

Cross-functional collaboration

Leadership and mentoring

Formation

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

Description du poste

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.