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Key Responsibilities and Required Skills for a **Regulatory Analyst**

💰 $65,000 - $95,000

ComplianceLegalRisk ManagementAnalytics

🎯 Role Definition

The Regulatory Analyst serves as a key pillar of our governance, risk, and compliance (GRC) framework. You will be responsible for interpreting and analyzing a wide array of regulations, assessing their impact on our business operations, and developing strategies to ensure full compliance. This position involves proactive monitoring of the regulatory environment, preparing detailed reports and submissions for governing bodies, and collaborating with cross-functional teams to embed compliance into our processes. Your expertise will not only protect the organization from legal and financial penalties but also foster a culture of integrity and ethical conduct, enabling sustainable growth in a dynamic market.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Compliance Coordinator
  • Paralegal
  • Research Assistant
  • Quality Assurance Specialist

Advancement To:

  • Senior Regulatory Analyst
  • Compliance Manager
  • Regulatory Affairs Manager
  • Director of Regulatory Affairs

Lateral Moves:

  • Risk Analyst
  • Policy Advisor
  • Data Privacy Analyst
  • Internal Auditor

Core Responsibilities

Primary Functions

  • Monitor, research, and interpret new and existing federal, state, and international regulations to determine their impact on company operations, products, and services.
  • Conduct comprehensive regulatory impact assessments and communicate findings, potential risks, and strategic recommendations to senior management and key stakeholders.
  • Prepare, compile, and submit accurate and timely regulatory filings, applications, registrations, and reports to various government agencies (e.g., FDA, SEC, EPA, FINRA).
  • Develop and maintain a centralized repository of regulatory intelligence and compliance documentation for organizational reference and audit purposes.
  • Collaborate with Legal, Product, and Engineering teams to provide regulatory guidance throughout the product development lifecycle, from conception to post-market surveillance.
  • Lead the review and analysis of marketing materials, product labeling, and external communications to ensure compliance with advertising and promotional standards.
  • Manage and respond to inquiries from regulatory agencies, providing clear, concise, and well-documented information in a timely manner.
  • Design and implement internal compliance policies, procedures, and controls to mitigate regulatory risks and ensure adherence to applicable laws.
  • Conduct and support internal audits and risk assessments to identify compliance gaps, weaknesses in controls, and areas for process improvement.
  • Develop and deliver targeted compliance training programs for employees across various departments to foster a strong culture of regulatory awareness and accountability.
  • Track legislative and regulatory changes through monitoring services and government sources, providing proactive analysis and strategic advice on potential future compliance obligations.
  • Serve as the subject matter expert on specific regulatory domains relevant to the industry, providing guidance and interpretation to internal teams.
  • Investigate, document, and manage compliance-related incidents or non-conformance issues, and develop robust corrective and preventive action plans (CAPAs).
  • Facilitate and coordinate external regulatory inspections and audits, acting as a primary point of contact and ensuring the timely provision of required information.
  • Analyze complex datasets to monitor compliance metrics, identify emerging trends, and generate insightful reports for leadership review and strategic decision-making.
  • Maintain and update critical regulatory affairs documentation, including technical files, design history files, and other required records to support product approvals and licenses.

Secondary Functions

  • Participate in industry trade associations and regulatory forums to stay abreast of emerging trends, best practices, and policy discussions.
  • Support the due diligence process for mergers and acquisitions by evaluating the target company's regulatory compliance posture and potential risks.
  • Assist in the development and maintenance of the company's business continuity plan from a regulatory compliance perspective.
  • Contribute to the organization's public policy and government affairs strategy by providing data-driven regulatory insights and analysis.
  • Mentor junior analysts or coordinators within the compliance team, sharing knowledge and best practices to foster team growth.
  • Review and negotiate regulatory-specific clauses within contracts and agreements with vendors, partners, and customers.

Required Skills & Competencies

Hard Skills (Technical)

  • Regulatory Research & Interpretation: Expertise in using legal and regulatory databases like Westlaw, LexisNexis, and industry-specific portals to find and interpret relevant statutes.
  • Regulatory Submission Management: Proven ability to compile and manage complex submissions and filings with government agencies.
  • Compliance Auditing: Experience in planning and conducting internal audits and risk assessments based on established methodologies (e.g., COSO).
  • GRC Software Proficiency: Familiarity with Governance, Risk, and Compliance (GRC) platforms such as Archer, MetricStream, or similar systems.
  • Data Analysis and Reporting: Strong skills in using tools like Excel (advanced functions), SQL, Tableau, or Power BI to analyze data and create meaningful reports.
  • Technical Writing: Ability to draft clear, concise, and accurate documentation, including policies, procedures, and formal correspondence.
  • Domain-Specific Knowledge: Deep understanding of specific regulatory frameworks relevant to the hiring industry (e.g., FDA 21 CFR, GDPR, SOX, FINRA, HIPAA).

Soft Skills

  • Analytical and Critical Thinking: Superior ability to dissect complex regulations, identify key requirements, and assess business impact.
  • Meticulous Attention to Detail: An exceptional eye for accuracy and precision, crucial for error-free filings and policy creation.
  • Effective Communication: Excellent written and verbal communication skills to clearly articulate complex regulatory concepts to diverse audiences, from engineers to executives.
  • Project Management: Strong organizational skills with the ability to manage multiple projects, prioritize tasks, and meet tight deadlines.
  • Strategic Problem-Solving: Proactive in identifying potential issues and developing practical, effective solutions to ensure compliance.
  • Stakeholder Management: Adept at building relationships and collaborating effectively with cross-functional teams and external regulators.
  • Adaptability: Ability to thrive in a fast-paced, dynamic environment and navigate ambiguity with confidence.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's Degree

Preferred Education:

  • Master's Degree (e.g., JD, MPP, MBA) or relevant professional certification (e.g., CCEP, RAC)

Relevant Fields of Study:

  • Public Policy
  • Law/Legal Studies
  • Business Administration
  • Finance
  • Life Sciences (for Pharma/MedTech)

Experience Requirements

Typical Experience Range:

  • 2-5 years of direct experience in a regulatory, compliance, or legal role.

Preferred:

  • Experience within a highly regulated industry such as finance, healthcare, pharmaceuticals, energy, or technology is strongly preferred.
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