Senior Assistant General Counsel - FDA Attorney

Altria

Overview: <b> 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!</b> <br> We are currently seeking a highly qualified <b>Senior Assistant General Counsel - FDA Attorney</b> with FDA regulatory and compliance experience to join our Law Department. The position is in <b>Richmond, VA</b> or we are <b>open to remote work arrangements</b> and reports to ALCS Vice President and Associate General Counsel. <br> 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 Altria Group and its companies. While there may be some variability, the primary role of counseling will be for tobacco products in the U.S. market. <b><br> What you’ll be doing:</b> <br> <ul> <li>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.</li> <li>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. </li> <li>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.</li> <li>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 </li> <li>Advise the business on product, research, and regulatory requirements in support of international initiatives. </li> <li>Handle special projects as necessary.</li> </ul> <b><br> Specific Skills required:</b> <br> 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. <br> 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. <br> 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 <br> In addition to the opportunity to apply and develop your skills toward key business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package. <br> People Leader Expectations: <p> In this role, you are responsible for leading a team. People Leaders play a fundamental role in bringing Altria’s Employment Brand to life and creating an exceptional employee experience. As a People Leader at Altria, you are responsible for the performance, capability and engagement of your team. Some examples of specific responsibilities aligned to People Leader expectations include:</p> <ul> <li>Establish and effectively communicate Vision, strategies and how each employee’s work aligns</li> <li>Identify, select, develop and allocate skills, behaviors and talent needed to meet business needs</li> <li>Embrace diverse perspectives, appreciate differences and foster a culture of inclusion</li> <li>Build trusting relationships by being authentic, transparent and providing radical candor</li> </ul> Sponsorship: Immigration Sponsorship is not available for this role. Total Rewards: <p> The starting salary is based on but not limited to experience, knowledge, and qualifications in determining compensation decisions. The Salary Range for this position is: $198,100.00 - $346,600.00 / annually.</p> <p> We deliver a market-competitive, equitable pay with a Total Reward program that includes:</p> <ul> <li> Annual performance incentive based on individual and company performance</li> <li> Competitive Medical, Dental, and Vision insurance to support you and your loved ones</li> <li> Flexible Work Environment to include vacation and generous holidays</li> <li> Deferred Profit-Sharing Plan (401K) with matching contributions on day 1, including a yearly company contribution</li> <li> Paid Paternity and Maternity Leave</li> <li> Employee Recognition Awards</li> <li> Student Loan Assistance</li> <li> To learn more about How to Support you and your Loved Ones, Work-Life Balance, and Invest into your Future, visit our additional benefits at Benefits (altria.com)</li> </ul> Company Overview: Altria is a Fortune 200 company that has a leading portfolio of tobacco products for U.S. tobacco consumers 21+. Our Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We are Moving Beyond Smoking™, leading the way in moving adult smokersaway from cigarettes by taking action to transition millions to potentially less harmful choices. At Altria, we celebrate the power of diverse teams working together to shape our future. Each Altria company is an equal opportunity employer. We are committed to providing individuals with criminal records, including formerly incarcerated individuals and individuals with conviction records, a fair chance at employment. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and ourshareholders. Altria is the parent company of Philip Morris USA, John Middleton, U.S. Smokeless Tobacco, on!, and NJOY. Altria complements its tobacco portfolio with equity investments in Anheuser-Busch InBev and Cronos Group. Learn more about Altria’s products and operating companies by visiting www.altria.com . Learn more about Altria at www.altria.com and follow us on LinkedIn
Posted
Closed
Practice Areas
FDA
Specialties
Compliance/Regulatory, Pharmaceuticals
Experience
10+ years
Type
Law Firm