Description:

Overview:
Provide strategic advice and legal support on a wide variety of domestic and international regulatory, product, research, quality, and manufacturing issues for a fortune 200 company with some of the most iconic brands! Have a law degree and experience with FDA compliance laws, regulations and with premarket product development, ideally in the tobacco, pharmaceutical or medical device industries? If so, we want to speak with you!

We are currently seeking a highly qualified Senior Assistant General Counsel - FDA Attorney with FDA regulatory and compliance experience to join our Law Department. The position is in Richmond, VA or we are open to remote work arrangements and reports to ALCS Vice President and Associate General Counsel.

This position is within the Law Department's Product and Intellectual Property Law Support Group, which provides legal counsel on regulatory, product research and development, regulatory science, product quality and manufacturing, and intellectual property matters affecting A Tobacco Company and its companies. While there may be some variability, the primary role of counseling will be for tobacco products in the U.S. market.

What You'll Be Doing:

Advise our businesses and their leaders regarding multiple issues of first impression surrounding the proper interpretation of evolving FDA tobacco product regulation and on FDA's likely interpretation of governing statutes and policies.
Advise the business on FDA, state and federal and other legal and strategic issues surrounding product research and development, regulatory reporting, and premarket product authorizations.
Collaborate with other members of the Law Department to develop legal and regulatory positions with respect to FDA matters and other administrative agency processes. Working with regulatory affairs and other functions to draft such positions for submission to relevant dockets and for other regulatory communications.
Assist clients to ensure legal compliance with relevant laws, regulations, and other legal requirements impacting premarket product authorizations, research and development, manufacturing, quality and FDA engagement, including the federal Tobacco Control Act, FDA regulations and Guidance, state and international regulatory reporting, product and packaging-related laws, the Master Settlement Agreement, and the Company's Policies
Advise the business on product, research, and regulatory requirements in support of international initiatives.
Handle special projects as necessary.

Specific Skills required:
Recent FDA regulation of tobacco products presents a rare and challenging opportunity to work on novel legal and business issues. Candidates must be highly motivated to analyze an evolving statutory regime, predict FDA's potential positions, and work diligently and creatively to responsibly achieve business objectives. We are looking for candidates who have demonstrated outstanding abilities and legal experience in FDA and other regulatory matters. Experience with FDA compliance laws and regulations and with premarket product development, ideally in the tobacco, pharmaceutical or medical device industries, will be important factors in evaluating candidates.

The candidate must be highly capable of operating in a fast-paced environment, must show strategic thinking and attention to detail, and must have strong organizational and communications skills. Qualified candidates should be able to handle multiple, conflicting priorities in a constantly changing environment, managing substantial workload and client expectations, and interacting with all management levels. The individual also must demonstrate reliability, good judgment, teamwork, time management, and effective legal research, writing and analytical skills.

JD from an accredited law school and good standing member of the Bar. 10+ years of experience in a law firm, corporate legal department, federal or state government agency, or related field