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Fda Regulatory Counsel Jobs (NOW HIRING)

Symbiotic Services

Senior Regulatory Counsel

Greensboro, NC · Hybrid

$135K - $183K/yr

Provide legal counsel on federal and state regulatory matters, including FDA submissions, labeling, marketing, and enforcement. Lead regulatory legal strategy and manage regulatory litigation and ...

Essilor

Regulatory Counsel

Manhattan, NY · On-site

Advise and counsel internal clients on a wide range of regulatory issues facing the Company in ... and FDA and Health Canada-related issues * Monitor proposed and enacted state/provincial and ...

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How much do fda regulatory counsel jobs pay per year?

As of Aug 16, 2026, the average yearly pay for fda regulatory counsel in the United States is $137,408.00, according to ZipRecruiter salary data. Most workers in this role earn between $100,000.00 and $166,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Counsel?

To thrive as an FDA Regulatory Counsel, you need a Juris Doctor (JD) degree, bar admission, and a deep understanding of FDA laws and regulations governing pharmaceuticals, medical devices, or food products. Familiarity with regulatory databases, legal research tools like Westlaw or LexisNexis, and experience with submission systems such as the FDA’s Electronic Submissions Gateway are typically required. Excellent analytical thinking, attention to detail, and strong written and verbal communication skills help you interpret regulations and advise clients or organizations effectively. These qualifications ensure compliance, minimize legal risk, and support successful product development and market entry.

What are common challenges faced by FDA Regulatory Counsel when advising on product approvals?

FDA Regulatory Counsel often encounter challenges navigating complex and evolving regulatory requirements, especially when advising on novel products or technologies. Ensuring compliance while balancing business objectives requires staying current with guidance updates and interpreting ambiguous regulations. Additionally, they must coordinate closely with cross-functional teams—including R&D, clinical, and marketing—to anticipate regulatory risks and devise strategic solutions. Effective communication and problem-solving skills are essential to manage these challenges and support successful product approvals.

What is the difference between Fda Regulatory Counsel vs Fda Compliance Specialist?

AspectFda Regulatory CounselFda Compliance Specialist
CredentialsLaw degree, bar admission, regulatory law experienceDegree in life sciences, regulatory affairs, or related field
Work EnvironmentLegal departments, law firms, regulatory agenciesManufacturers, healthcare companies, regulatory agencies
Industry UsageLegal advice, regulatory strategy, compliance issuesMonitoring compliance, preparing reports, implementing policies

Fda Regulatory Counsel primarily provides legal guidance on FDA regulations, focusing on legal compliance and regulatory strategy. In contrast, Fda Compliance Specialists focus on ensuring that products and processes meet FDA standards through monitoring and reporting. Both roles require understanding FDA regulations but differ in their core responsibilities and work environments.

What is an FDA Regulatory Counsel?

FDA Regulatory Counsels are legal professionals who advise companies, organizations, or government agencies on compliance with regulations set by the U.S. Food and Drug Administration (FDA). They help interpret and apply complex FDA laws and regulations related to drugs, medical devices, food, cosmetics, and other products. These counsels play a critical role in ensuring that products meet all legal requirements for safety, efficacy, and marketing. Additionally, they often represent clients during FDA inspections, investigations, and enforcement actions, and assist in preparing submissions for product approvals.
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Fda Regulatory Counsel jobs near you
Infographic showing various Fda Regulatory Counsel job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $137,408 per year, or $66.1 per hour.

Vice President, Compliance & Regulatory Counsel

AVEO Oncology

Boston, MA • Remote

Full-time

Posted 19 days ago

Job description

JOB TITLE: Vice President, Compliance & Regulatory Counsel 

REPORTS TO: Senior Vice President, General Counsel

LOCATION: Boston, MA                                                                  

DATE PREPARED: APRIL 1, 2026

JOB SUMMARY: 

The Compliance & Regulatory Counsel is responsible for advising on a variety of healthcare related legal, regulatory and compliance issues governing on-market and pipeline products, with a primary focus on the Anti-Kickback Statute, False Claims Act and advertising and promotional regulations. The Compliance & Regulatory Counsel will work closely with senior management, members of the legal department and other business departments, as needed. The Compliance & Regulatory Counsel will report directly to the General Counsel and serve as the Chief Compliance Officer. The Compliance & Regulatory Counsel will manage and support daily activities relating to pharmaceutical compliance. The Compliance & Regulatory Counsel will be involved in the oversight and management of AVEO’s compliance and ethics program, ensuring that AVEO exercises due diligence and sound internal controls to operate with integrity and protect against legal risks. The Compliance & Regulatory Counsel will: (1) implement robust compliance policies and procedures to meet all regulatory standards and state and federal guidelines; (2) maintain, implement and manage all training on compliance-related subjects and processes; (3) monitor employee compliance with policies and procedures; (4) assist in investigations, as necessary; and (5) maintain and manage transparency reporting under the Sunshine Act and relevant state laws. The Compliance & Regulatory Counsel will keep abreast and monitor all state and federal regulations affecting the pharmaceutical industry and report upcoming changes in federal and/or state laws. The Compliance & Regulatory Counsel will also review and draft legal documents and advise employees on legal and regulatory issues related to vendors, projects, and sales and marketing.

PRINCIPAL DUTIES:   

·       Provide clear and substantive advice to senior management and business clients (Commercial Sales Force, Marketing, Market Access, Medical Affairs and Regulatory Affairs departments) on a broad range of legal, regulatory and compliance issues focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange. These include FDA regulations, False Claims Act, AntiKickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act and competition law in connection with product labeling, promotional and non-promotional activities.

·       Advise cross-functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use.

·       Provide counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors.

·        Review business materials (including brand plans, promotions, medical plans and training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics.

·        Provide legal advice and assistance for the development of policies and training, and conducts training.

·       Collaborate with R&D and IP colleagues involved with late stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products.

·       Advise the General Counsel of project developments in a timely manner. Execute core job responsibilities in a timely manner.

·       Provide subject matter expertise on a variety of agreements including: complex commercial agreements, third party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.

·       Keep abreast of regulatory developments to identify the potential impact to AVEO’s business.

·       Identify potential areas of compliance risk and vulnerability, and help develop additional policies and procedures to help minimize that risk.

·       Manage vendor and other third-party screenings to identify and mitigate potential corruption and other risks to the company.

·       Assist with the development and delivery of compliance training programs.

·       Compile and analyze information from such legal reviews to propose revisions to compliance policies and procedures as needed.

·       Help select and direct the work of outside counsel, define project objectives, manage project and budget, as needed.

·       Contribute to the development of AVEO’s compliance focused culture.

·       Perform other duties as assigned.

BASIC QUALIFICATIONS:

 

·       Provide clear and substantive advice to senior management and business clients (Commercial Sales Force, Marketing, Market Access, Medical Affairs and Regulatory Affairs departments) on a broad range of legal, regulatory and compliance issues focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange. These include FDA regulations, False Claims Act, AntiKickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act and competition law in connection with product labeling, promotional and non-promotional activities.

·       Advise cross-functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use.

·       Provide counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors.

·       Review business materials (including brand plans, promotions, medical plans and training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics.

·       Provide legal advice and assistance for the development of policies and training, and conducts training.

·       Collaborate with R&D and IP colleagues involved with late stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products.

·       Advise the General Counsel of project developments in a timely manner. Execute core job responsibilities in a timely manner.

·       Provide subject matter expertise on a variety of agreements including: complex commercial agreements, third party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.

·       Keep abreast of regulatory developments to identify the potential impact to AVEO’s business.

·       Identify potential areas of compliance risk and vulnerability, and help develop additional policies and procedures to help minimize that risk.

·       Manage vendor and other third-party screenings to identify and mitigate potential corruption and other risks to the company.

·       Assist with the development and delivery of compliance training programs.

·       Compile and analyze information from such legal reviews to propose revisions to compliance policies and procedures as needed.

·       Help select and direct the work of outside counsel, define project objectives, manage project and budget, as needed.

·       Contribute to the development of AVEO’s compliance focused culture.

·       Perform other duties as assigned.

·       7+ years in the U.S. and International healthcare compliance experience.

·       Experience with a senior compliance role in global cross-cultural and cross-functional teams, including implementation of global compliance programs.

·       Project Management and System Implementation experience.

·       High risk awareness and risk management skills.

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.