Senior Regulatory Counsel

Overview

A leading tobacco company in the United States is seeking a Senior Regulatory Counsel to join their Legal and Regulatory team. This senior-level position will report to the Head of Regulatory Law and focus on federal and state regulatory matters affecting tobacco and nicotine products. The role requires deep expertise in FDA regulation, multi-state compliance, and regulatory litigation, with the ability to navigate emerging legal and regulatory issues. The position is critical for shaping regulatory strategy, managing risk, and ensuring compliance in a complex and evolving legal environment.

Responsibilities

• Provide expert legal counsel on federal and state regulatory compliance related to tobacco and nicotine products.
• Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and reporting.
• Lead legal strategy and support for regulatory litigation and administrative proceedings.
• Monitor, interpret, and communicate regulatory developments across all 50 states, including flavor bans and other emerging restrictions.
• Oversee legal aspects of state regulatory compliance, including Master Settlement Agreement (MSA) certifications and fire-safe cigarette applications.
• Advise on Freedom of Information Act (FOIA) requests and responses, including strategy, redactions, and risk mitigation.
• Partner with Quality and Regulatory Affairs teams to support consumer complaint intake, quality reporting, and related compliance obligations.
• Develop and implement proactive legal strategies to navigate complex regulatory environments and support business objectives.
• Collaborate cross-functionally with Regulatory Science and Affairs, Corporate Legislative Affairs, Marketing, Sales, and Operations to align legal guidance with operational goals.
• Represent the organization in interactions with regulatory agencies, industry groups, and external counsel.
• Draft, review, and negotiate regulatory-related agreements and documents.
• Educate and advise internal stakeholders on regulatory requirements, litigation risk, and compliance strategies.

Requirements

• Juris Doctor (JD) degree from an accredited law school.
• Active license to practice law in at least one U.S. jurisdiction.
• Minimum of 10 years of legal experience in a highly regulated industry such as tobacco, pharmaceuticals, or medical devices.
• Strong background in FDA regulatory matters, state regulatory compliance, regulatory litigation, and FOIA.
• Experience advising on Premarket Tobacco Product Applications (PMTA) and regulatory strategy.
• Must be 21 years of age or older.

Skills & Competencies

• Proven ability to interpret and apply complex regulations to business operations with a strategic and solutions-oriented mindset.
• Strong communication, negotiation, and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Strong strategic thinking and business acumen.
• Proficiency in Microsoft Office and Microsoft Teams.

Work Environment and Physical Demands

• Ability to travel as needed.
• Requires light physical effort; occasionally lifts or moves objects under 10 lbs.
• May involve prolonged periods of walking, sitting, or standing.
• Requires prolonged use of computer and keyboard equipment, manual dexterity, and fine motor skills.

Compensation & Benefits

• Competitive benefits package including medical, dental, vision, life insurance, and disability plans.
• 401(k) plan with dollar-for-dollar match up to 6% and 5% annual company contribution.
• 15 company-paid holidays.
• Generous paid time off.
• Employee recognition and discount programs.
• Education assistance.
• Employee referral bonus program.
• Hybrid work environment with remote and in-office options.
• Summer hours.
• Casual dress policy Monday through Friday.

Location

This position offers a hybrid workplace arrangement with both remote and in-office work options.