Legal

Regulatory Affairs Counsel job description

A Regulatory Affairs Counsel provides strategic legal guidance, ensures compliance with FDA/EMA standards, and mitigates risk for complex corporate operations.

Published September 6, 2025Updated May 16, 20264645 likes

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Job brief

We are looking for a highly analytical Regulatory Affairs Counsel to join our legal team and safeguard our business in a rapidly evolving regulatory environment. In this role, you will be the primary legal advisor on compliance matters, collaborating with cross-functional teams to ensure that our innovative products meet all legal and ethical standards from conception to market release. You will have the unique opportunity to shape our regulatory strategy, influence company-wide policies, and mitigate enterprise-level risks. If you are passionate about the nexus of law and industry innovation, we want to hear from you.

Key highlights

Manage direct communications and correspondence with regulatory agencies such as the FDA, EMA, or other relevant government bodies during investigation cycles.
Draft and execute comprehensive legal risk assessments regarding product safety, clinical trial data, and international regulatory filings for internal stakeholders.
Review and approve marketing collateral, product labeling, and technical documentation to ensure full compliance with established advertising and promotional regulations.
Coordinate with intellectual property and business development teams to perform regulatory due diligence during mergers, acquisitions, or strategic partnership negotiations.

What is a Regulatory Affairs Counsel?

A Regulatory Affairs Counsel is a specialized legal professional who bridges the intersection of corporate law, government agency compliance, and internal governance. The Regulatory Affairs Counsel identifies regulatory hurdles and legal risks associated with product development, market entry, and operational shifts. By utilizing expertise in legislative frameworks, such as the Federal Food, Drug, and Cosmetic Act or international equivalent standards, they draft essential documentation and provide counsel that ensures the organization maintains its license to operate while minimizing liability in a highly scrutinized regulatory landscape.

What does a Regulatory Affairs Counsel do?

A Regulatory Affairs Counsel spends their day interpreting complex regulatory statutes and translating them into actionable business strategies for leadership and operations teams. They review clinical study protocols, labeling, and marketing materials for compliance, often engaging directly with regulatory bodies like the FDA, FTC, or global health authorities during submission processes. Beyond external liaison work, they maintain robust corporate record-keeping systems, draft internal compliance policies, and conduct deep-dive legal research into emerging legislation that could affect the company’s product lifecycle or market compliance posture.

Key responsibilities

Draft and execute comprehensive legal risk assessments regarding product safety, clinical trial data, and international regulatory filings for internal stakeholders.
Manage direct communications and correspondence with regulatory agencies such as the FDA, EMA, or other relevant government bodies during investigation cycles.
Review and approve marketing collateral, product labeling, and technical documentation to ensure full compliance with established advertising and promotional regulations.
Conduct exhaustive legal research on emerging administrative laws and industry standards, providing actionable summaries to senior leadership on potential business impacts.
Collaborate with internal compliance officers to update and maintain corporate governance frameworks, SOPs, and ethics manuals to prevent regulatory violations.
Provide legal counsel during internal and external audits, ensuring all documentation is accurate, complete, and readily accessible for regulatory inspection.
Coordinate with intellectual property and business development teams to perform regulatory due diligence during mergers, acquisitions, or strategic partnership negotiations.
Monitor global legislative trends to advise on the development of long-term strategies that balance operational growth with strict legal and safety compliance.

Requirements and skills

Juris Doctor (JD) degree from an accredited law school and active state bar admission in good standing.
4+ years of experience specializing in regulatory law, ideally within a highly regulated industry such as pharmaceuticals, medical devices, or biotechnology.
Proven proficiency in interpreting and applying statutes like the Food, Drug, and Cosmetic Act, HIPAA, or ISO 13485 standards.
Expertise in drafting complex legal instruments, including consent decrees, regulatory submissions, and commercial service agreements.
Demonstrated ability to translate opaque legal requirements into clear, concise executive-level guidance for non-legal stakeholders.
Experience managing the lifecycle of regulatory inquiries, including responding to warning letters or managing voluntary product recalls.
Strong technical skills in using legal research databases like Westlaw or LexisNexis to support evidence-based legal conclusions.
Certification in Healthcare Compliance (CHC) or equivalent professional credential is highly preferred for candidates.

FAQs

What does a Regulatory Affairs Counsel do on a daily basis?

A Regulatory Affairs Counsel is responsible for balancing legal compliance with commercial strategy. Daily tasks include reviewing marketing materials for regulatory adherence, drafting responses to government agency inquiries, conducting legal research on new legislation, and advising internal product teams on how to mitigate liability. They act as the primary legal liaison between the company's operations and the regulatory bodies that govern their industry.

What qualifications are needed to become a Regulatory Affairs Counsel?

To become a Regulatory Affairs Counsel, you must possess a Juris Doctor (JD) degree and maintain an active license to practice law. Beyond legal education, candidates need a deep understanding of industry-specific regulatory frameworks—such as FDA guidelines for pharma or medical devices—and experience with compliance audits. Strong writing skills, negotiation capabilities, and the ability to simplify complex legal concepts for non-legal executives are also critical qualifications.

Who does a Regulatory Affairs Counsel work with in an organization?

The Regulatory Affairs Counsel collaborates across the entire organization, including close partnerships with clinical research teams, marketing and advertising departments, and business development leads. They also work extensively with external entities, including federal regulators, government inspectors, and outside counsel. Internally, they report to the General Counsel or Chief Compliance Officer to align regulatory strategies with the company's broader corporate risk profile.

Why is a Regulatory Affairs Counsel important for a business?

A Regulatory Affairs Counsel is essential because they protect the organization from catastrophic legal risk, fines, and market exclusion. By ensuring that products and business processes strictly adhere to ever-changing government regulations, they safeguard the company’s reputation and bottom line. Their ability to foresee legal obstacles before they escalate into litigation or regulatory intervention is a key driver of long-term business sustainability.