Regulatory Affairs Director: Strategy & Compliance

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

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.