Key Responsibilities and Required Skills for Regulatory Compliance Director

🎯 Role Definition

The Regulatory Compliance Director is a senior compliance leader who builds and operates an effective, scalable compliance program aligned to business objectives and regulatory expectations. This role leads regulatory strategy, interpretation of laws and rules, policy and procedure development, monitoring and testing, remediation of compliance gaps, regulatory engagement, and enterprise-wide training. The Director partners with Legal, Risk, Finance, Operations and Product teams to embed controls, reduce legal and regulatory risk, and ensure timely and accurate reporting to regulators and senior executives.

Key SEO / LLM keywords included: Regulatory Compliance Director, compliance program, regulatory strategy, risk management, audits, internal controls, regulatory filings, policy development, FDA, GDPR, HIPAA, SOX, AML, compliance training, regulatory affairs.

📈 Career Progression

Typical Career Path

Entry Point From:

Compliance Manager / Senior Compliance Manager
Regulatory Affairs Manager / Regulatory Affairs Lead
Senior Legal Counsel with regulatory focus

Advancement To:

Chief Compliance Officer (CCO)
Senior Vice President (SVP), Compliance & Risk
General Counsel / Head of Legal & Compliance

Lateral Moves:

Director, Enterprise Risk Management
Director, Internal Audit
Head of Data Privacy / Chief Privacy Officer

Core Responsibilities

Primary Functions

Develop, implement, and continuously improve an enterprise-wide compliance program that aligns with business strategy and regulatory requirements across multiple jurisdictions (e.g., FDA, GDPR, HIPAA, SOX, AML), ensuring scalability for growth and new products.
Lead interpretation of complex regulations and guidance, translating legal and regulatory requirements into pragmatic policies, standard operating procedures (SOPs), and operational controls used by business teams.
Design, execute, and oversee risk-based monitoring and testing programs (compliance testing, control effectiveness reviews, surveillance) to identify gaps, assess root causes, and recommend sustainable remediation plans.
Lead and/or coordinate regulatory filings, notifications, and submissions; act as primary liaison for inspections, regulatory exams, and agency inquiries, preparing briefing materials and managing responses to regulators and external auditors.
Provide subject matter expertise on regulatory strategy for product development, product launches, contractual arrangements, and strategic initiatives; partner with Product, Engineering, and Operations to embed compliance by design.
Establish and maintain a formal compliance risk assessment framework and periodic risk register; prioritize mitigation activities based on risk appetite and business impact.
Manage and lead cross-functional remediation projects, ensuring corrective actions are implemented on time, validated for effectiveness, and reported to senior leadership and regulators as required.
Oversee compliance investigations, whistleblower reports, and breach response activities; coordinate with Legal and HR on investigatory process, evidence preservation, disciplinary actions, and remedial measures.
Build and deliver a targeted compliance training and awareness program for all levels of the organization, including role-based training, executive briefings, and board-level reporting on compliance posture.
Develop key performance indicators (KPIs) and metrics to measure compliance program effectiveness; produce regular dashboards and executive reports for the Board, Audit Committee, and senior leadership.
Manage third-party compliance risk: vendor due diligence, contract clauses, ongoing monitoring, and remediation expectations tied to critical suppliers and partners.
Lead and mentor a high-performing compliance team, including hiring, performance management, professional development, and fostering a culture of ethical behavior and accountability.
Collaborate with Legal Counsel on contract review, regulatory language, product labeling, promotional materials, and policy alignment to minimize regulatory exposure and litigation risk.
Drive enterprise policy lifecycle management: draft new policies, maintain and update existing policies, manage approvals and version control, and ensure enterprise-wide dissemination and adoption.
Implement and maintain internal controls and processes to ensure accuracy and completeness of required regulatory reporting and certifications; coordinate SOX readiness and testing when applicable.
Conduct trend analysis of regulatory developments, enforcement actions, and industry best practices; proactively recommend strategic changes to stay ahead of regulatory shifts and to capitalize on compliance as a competitive advantage.
Serve as an escalation point for complex compliance questions and ensure timely, defensible positions are adopted in documentation and communications.
Prepare and present compliance program updates, audit findings, and regulatory engagement outcomes to the Board of Directors, Audit/Compliance Committees, and executive leadership.
Coordinate with Finance and IT on data integrity, retention, security controls, and privacy compliance (e.g., GDPR, CCPA), ensuring data-related regulatory obligations are met.
Lead crisis response on compliance-related incidents, including coordinating cross-functional teams for containment, remediation, regulator notifications, and public communications as appropriate.
Oversee licensing, registrations, and certifications necessary for operations, ensuring renewals and submissions are timely and meet statutory requirements.
Evaluate and implement compliance technology and automation tools (GRC platforms, monitoring solutions, case management) to improve efficiency, evidence collection, and reporting capabilities.
Ensure proper documentation of compliance decisions, investigations, audits, and remediation activities to maintain audit trails and to support regulatory examinations or litigation defense.

Secondary Functions

Provide subject matter input into internal and external audits; support auditors with documentation, evidence, and remediation status updates.
Create templates, playbooks, and checklists to streamline regulatory submissions, inspection readiness, and operational compliance checks.
Support commercial teams with compliance review for marketing materials, promotions, sponsorships, and communications to ensure claims and content meet regulatory and advertising standards.
Assist HR with development of employee conduct standards, conflict of interest disclosures, and disciplinary processes related to compliance violations.
Maintain a regulatory horizon scanning process to flag upcoming laws, rule changes, and enforcement trends; provide actionable briefings and playbooks to impacted teams.
Collaborate with IT and Security on incident response procedures where potential regulatory impact exists (e.g., data breaches affecting regulatory reporting).
Participate in industry working groups, trade associations, and regulatory roundtables to shape policy discussions and gain early insight into regulatory direction.
Support product and business development teams during due diligence for partnerships, acquisitions, and market entry to assess regulatory implications and integration plans.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of regulatory regimes and compliance frameworks relevant to the industry (e.g., FDA regulations & 21 CFR for life sciences; HIPAA for healthcare; GDPR/CCPA for privacy; SOX for financial controls; AML/KYC for financial services).
Regulatory strategy development and implementation experience, including drafting policies, SOPs, and regulatory submissions.
Experience designing and running risk-based monitoring, internal controls testing, and remediation programs (including SOX/ITGC experience where applicable).
Audit management skills: planning, executing, responding to internal and external audits and regulatory examinations.
Investigation and case management experience including evidence collection, interviews, root-cause analysis, and formal reporting.
Vendor and third-party risk management, including contract structuring for regulatory protections and oversight programs.
Familiarity with Governance, Risk, and Compliance (GRC) tools, compliance monitoring software, and analytics platforms.
Data privacy and cybersecurity regulatory knowledge; working experience with privacy impact assessments and breach notification obligations.
Strong knowledge of corporate licensing, registration processes, and maintenance of regulatory records and filings.
Financial controls and reporting knowledge (experience with SOX, compliance attestations, and regulatory financial disclosures).
Experience leading regulatory inspections and preparing inspection-ready documentation and mock inspections.
Legal drafting and interpretation skills, including ability to work with corporate counsel on complex regulatory language and compliance risk mitigation.

Soft Skills

Strategic thinker with the ability to translate regulatory requirements into practical business solutions and commercial-friendly controls.
Strong leadership and people management skills, including team building, mentorship, and performance management.
Excellent written and verbal communication skills with ability to present complex compliance topics to executive teams and boards.
Influential stakeholder management and cross-functional collaboration skills; ability to negotiate and align conflicting priorities across business units.
High level of integrity, independence, and sound judgment; capacity to act as trusted advisor and escalation point for ethical dilemmas.
Project and change management skills to lead remediation and compliance transformation initiatives on time and within budget.
Analytical mindset with strong attention to detail, documentation discipline, and comfort with data-driven decision making.
Resilient and adaptable to fast-changing regulatory environments and business needs.
Conflict resolution and investigative interviewing skills.
Customer-focused mindset to balance regulatory constraints with business objectives and user experience.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Law, Business Administration, Finance, Life Sciences, Public Policy, or related field.

Preferred Education:

Juris Doctor (JD), Master of Laws (LLM), MBA, or Master’s in Regulatory Affairs, Public Health or related advanced degree.
Professional certifications such as CCEP (Certified Compliance & Ethics Professional), CISM, CIPP/E, CAMS (Certified Anti-Money Laundering Specialist), CRC, CPA, or equivalent.

Relevant Fields of Study:

Law / Regulatory Affairs / Public Policy
Business / Finance / Accounting
Life Sciences / Healthcare (where industry-specific regulation applies)
Information Security / Data Privacy (for privacy-heavy roles)

Experience Requirements

Typical Experience Range:

10–15+ years of progressive regulatory compliance, legal, or regulatory affairs experience with at least 5+ years in a leadership role.

Preferred:

Demonstrated experience leading cross-functional compliance programs in regulated industries (e.g., healthcare, financial services, life sciences, fintech, telecom).
Track record managing regulatory interactions and successful outcomes in inspections, investigations, or enforcement matters.
Experience building compliance teams, implementing GRC tooling, and driving enterprise-wide compliance transformations.
History of working with international regulators and managing multi-jurisdictional compliance obligations.