Altria - Senior Counsel - FDA Regulatory Affairs
Company Name:
BITSOFT INTERNATIONAL, INC.
Job Description:
Altria Group is a FORTUNE 200 company that owns the premier tobacco companies in the United States including Philip Morris USA, U.S. Smokeless Tobacco Company, and John Middleton. The companies premium tobacco brands include Marlboro, Copenhagen, Skoal, and Black Mild. Altria also owns Nu Mark, an innovative tobacco products company with a product portfolio that includes MarkTen electronic cigarettes, Ste. Michelle Wine Estates, one of the countrys top premium wine producers and Philip Morris Capital Corporation, an investment company. Altrias mission is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products.
Altria Client Services role is to provide high-quality services to the Altria family of companies. We are currently seeking a highly qualified attorney with FDA-law experience to join our Law Department in Richmond, VA
This position is within the Law Departments Product and Intellectual Property Law Support Group, which provides legal counsel on regulatory, product research and development, product quality and manufacturing, and intellectual property matters affecting Altria Group and its companies.
The selected candidate will provide strategic advice and legal support on a wide variety of domestic and international regulatory, product, research, quality and manufacturing issues. The position is located in Richmond, VA. The position reports to ALCS Assistant General Counsel.
The responsibilities for this position will include:
Advising the business and its leaders regarding multiple issues of first impression surrounding the proper interpretation of evolving FDA tobacco product regulation under the newly enacted Tobacco Control Act of 2009 and on FDAs likely interpretation and policies.
Advising the business on FDA, state and federal and other legal issues surrounding product research and development, regulatory reporting, and premarket regulatory authorizations.
Collaborating 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 the business to draft such positions for submission to relevant dockets and for other regulatory communications.
Assisting clients to ensure legal compliance with relevant laws, regulations, and other legal requirements impacting 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 Companys Policies
Advising the business on product, research, and regulatory requirements in support of international initiatives
Handling special projects as necessary
Specific SkillsRecent 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 FDAs 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 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.
A law degree is required, with a solid record of academic achievement. The position requires a minimum of seven (7) years experience in a law firm, corporate legal department, federal or state government agency, or related area. Admission to a state bar is required.
At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development and advancement.
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 incentive compensation and deferred profit sharing programs as well as a relocation assistance package.Estimated Salary: $20 to $28 per hour based on qualifications.
BITSOFT INTERNATIONAL, INC.
Job Description:
Altria Group is a FORTUNE 200 company that owns the premier tobacco companies in the United States including Philip Morris USA, U.S. Smokeless Tobacco Company, and John Middleton. The companies premium tobacco brands include Marlboro, Copenhagen, Skoal, and Black Mild. Altria also owns Nu Mark, an innovative tobacco products company with a product portfolio that includes MarkTen electronic cigarettes, Ste. Michelle Wine Estates, one of the countrys top premium wine producers and Philip Morris Capital Corporation, an investment company. Altrias mission is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products.
Altria Client Services role is to provide high-quality services to the Altria family of companies. We are currently seeking a highly qualified attorney with FDA-law experience to join our Law Department in Richmond, VA
This position is within the Law Departments Product and Intellectual Property Law Support Group, which provides legal counsel on regulatory, product research and development, product quality and manufacturing, and intellectual property matters affecting Altria Group and its companies.
The selected candidate will provide strategic advice and legal support on a wide variety of domestic and international regulatory, product, research, quality and manufacturing issues. The position is located in Richmond, VA. The position reports to ALCS Assistant General Counsel.
The responsibilities for this position will include:
Advising the business and its leaders regarding multiple issues of first impression surrounding the proper interpretation of evolving FDA tobacco product regulation under the newly enacted Tobacco Control Act of 2009 and on FDAs likely interpretation and policies.
Advising the business on FDA, state and federal and other legal issues surrounding product research and development, regulatory reporting, and premarket regulatory authorizations.
Collaborating 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 the business to draft such positions for submission to relevant dockets and for other regulatory communications.
Assisting clients to ensure legal compliance with relevant laws, regulations, and other legal requirements impacting 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 Companys Policies
Advising the business on product, research, and regulatory requirements in support of international initiatives
Handling special projects as necessary
Specific SkillsRecent 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 FDAs 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 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.
A law degree is required, with a solid record of academic achievement. The position requires a minimum of seven (7) years experience in a law firm, corporate legal department, federal or state government agency, or related area. Admission to a state bar is required.
At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development and advancement.
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 incentive compensation and deferred profit sharing programs as well as a relocation assistance package.Estimated Salary: $20 to $28 per hour based on qualifications.
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