ZipRecruiter

Log In

1

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 ...

The Rockridge Group

Be Seen First

Senior FDA Regulatory Attorney

New York, NY · Remote

$250K - $350K/yr

Counsel clients regarding FDA regulations, guidance, inspections, investigations, warning letters, and enforcement actions. * Provide guidance on: * * Compounding (503A and 503B) * Drug Supply Chain ...

EssilorLuxottica

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 ...

Essilor

Regulatory Counsel

Manhattan, NY

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 ...

Ōura

Senior Product and Regulatory Counsel

$142K - $194K/yr

Senior Product and Regulatory Counsel We are looking for a Product and Regulatory Lead Counsel who ... Develop briefings for Senior leadership on significant developments in FDA, EU MDR, and other ...

Alto

OR

$139K - $189K/yr

The Commercial & Healthcare Regulatory Counsel is a hands-on attorney focused on commercial and ... Working knowledge of healthcare regulatory frameworks (e.g., AKS, HIPAA, FDA, DEA, PBM, state ...

next page

Showing results 1-20

All JobsFda Regulatory Counsel Jobs

Fda Regulatory Counsel information

See salary details

$69K

$137.4K

$199K

How much do fda regulatory counsel jobs pay per year?

As of Aug 8, 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.
More about Fda Regulatory Counsel jobs
What cities are hiring for Fda Regulatory Counsel jobs? Cities with the most Fda Regulatory Counsel job openings:
What states have the most Fda Regulatory Counsel jobs? States with the most job openings for Fda Regulatory Counsel jobs include:
What job categories do people searching Fda Regulatory Counsel jobs look for? The top searched job categories for Fda Regulatory Counsel jobs are:
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, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% 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 • On-site

Full-time

Posted 11 days ago

Job description

Description
JOB TITLE: Vice President, Compliance & Regulatory Counsel
REPORTS TO: Senior Vice President, General Counsel
LOCATION: Boston MA
DATE PREPARED: July 27, 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:
• Implement robust compliance policies and procedures to meet all regulatory standards and state
and federal guidelines.
• Maintain, implement and manage all training on compliance-related subjects and processes.
• Monitor employee compliance with policies and procedures.
• Assist in investigations, as necessary.
• 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, Anti-Kickback 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.
One Marina Park Drive | Boston, MA 02108 | 857-400-0101 | www.aveooncology.com
• 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.
• 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 vendors 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.
• Partner with Commercial, Medical Affairs, Market Access, Regulatory Affairs, and Clinical
Development to provide practical legal and compliance guidance.
• Support compliance risk assessments and recommend solutions to mitigate identified risks.
• Support compliance monitoring, auditing, and corrective action initiatives to strengthen the
compliance program.
• Provide legal and compliance guidance regarding healthcare professional (HCP) engagements,
including advisory boards, consulting arrangements, and speaker programs.
• Serve as the Legal representative on the Material Review Committee (MRC), providing legal and
regulatory guidance for promotional and medical review activities.
• Support compliance initiatives, regulatory inquiries, audits, and other cross-functional projects, as
needed.
• Contribute to the development of AVEO's compliance focused culture.
BASIC QUALIFICATIONS:
• Juris Doctor (J.D.) or equivalent from an accredited law school and admission in good standing to
a state bar.
• Minimum of 10+ years of relevant experience (combination of compliance-related inhouse
and/or law firm work experience).
• Experience in providing legal expertise/guidance to product development and strategy.
One Marina Park Drive | Boston, MA 02108 | 857-400-0101 | www.aveooncology.com
• Experience supporting a pharmaceutical commercialized brand required.
• Experience with leading educational sessions regarding compliance and branding for senior
leadership, key stakeholders, the legal team and the company.
• Experience in providing an enterprise view in developing and delivering legal guidance to internal
stakeholders.
• Possess significant expertise in all areas of U.S. laws and regulations including FDA, anti
kickback, antitrust, privacy and product liability.
• Experience in working with Market Access/Managed Health Care matters is desirable.
• Excellent client service and written/verbal communication skills required.
• High level of professionalism with strong judgment and commitment to ethical issues.
• Must be detail oriented with outstanding organizational skills and the proven ability to handle
multiple responsibilities simultaneously while maintaining high quality and performance under
pressure
• Ability to work independently and with a diverse set of personalities in a team environment.
• Results-driven, has a strong sense of urgency and is able to drive results.
• Business-minded and comfortable in an entrepreneurial, fast-paced environment where demands
and priorities change rapidly.
• Able to effectively interact with, influence and collaborate with other members of the
organization.
• Proven track record of learning quickly, taking initiative, working proactively, being resourceful,
and taking on additional responsibility.
ADDITIONAL PREFERRED QUALIFICATIONS/EXPERIENCE:
• 10+ 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.

Apply