Senior Director – Regulatory Intelligence, FDA Engagement

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and implement a global regulatory intelligence strategy.

• Oversee enterprise-wide impact assessments for major regulatory changes.

• Assess regulatory changes based on factors such as business, compliance, product, and patient risk.

• Facilitate cross-functional action plans and manage executive escalations.

• Develop governance frameworks, policies, procedures, and metrics for regulatory intelligence functions.

• Establish a centralized regulatory intelligence team that supports all product categories and global markets.

• Create long-term regulatory risk assessments and strategic forecasting capabilities.

• Recognize emerging regulatory trends and provide guidance to leadership on potential business effects.

• Generate dashboards that highlight regulatory changes, compliance risks, industry trends, emerging enforcement themes, and strategic opportunities.

• Act as the enterprise authority in crafting, reviewing, and approving regulatory response strategies.

• Lead the preparation of responses to FDA Form 483 observations, FDA Warning Letters, Untitled Letters, regulatory meeting commitments, requests for information, inspection follow-up correspondence, and compliance and enforcement actions.

• Ensure that regulatory responses are scientifically valid, strategically aligned, risk-based, defensible to regulators, and backed by suitable remediation plans.

• Guide cross-functional teams in navigating regulatory negotiations, commitments, and remediation efforts.

⛳️ Requirements

• Bachelor’s degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or a related discipline.

• Over 10 years of progressive experience in Regulatory Affairs and/or Quality leadership roles.

• More than 8 years of direct interaction with global health authorities.

• Substantial experience in highly regulated healthcare sectors, including Medical Devices, Pharmaceuticals/OTCs, Combination Products, Biologics, Human Tissue/HCT/P products, and Nutritional Supplements.

• Direct authorship experience with multiple FDA-483/Warning Letters and other communications with regulatory agencies.

• Extensive expertise in authoring, reviewing, and leading regulatory responses to FDA enforcement actions.

• Proven track record in directly authoring numerous FDA Warning Letter responses.

• Direct authorship of many FDA Form 483 responses.

• Experience in developing remediation commitments and implementation plans.

• Management of ongoing communication with the FDA regarding compliance commitments.

• Leadership in cross-functional teams supporting inspection responses and remediation activities.

• Experience in negotiating regulatory commitments and demonstrating the effectiveness of corrective actions.

• Preferred: Over 15 years of progressive experience in Quality and/or Regulatory leadership positions.

• Preferred: Experience in establishing or managing a Regulatory Intelligence function.

• Preferred: Experience in supporting enterprise-wide quality transformation or remediation initiatives.

• Preferred: Experience working across FDA, European Commission / EMA, Health Canada, PMDA, TGA, and MFDS jurisdictions.

• Preferred: Experience leading enterprise-level FDA remediation programs that involve multiple facilities, product lines, and compliance workstreams.

🏝️ Benefits

• Competitive total rewards package.

• Continuing education and training opportunities.

• Health insurance coverage.

• Life and disability insurance.

• 401(k) contributions.

• Paid time off.

• Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.

• Eligibility for bonuses and/or incentives.

• Opportunities for career growth.