Intellectual Property/Counsel/In House/Richmond, Virginia
Company Name:
BITSOFT INTERNATIONAL, INC.
Senior Counsel - FDA Regulatory Affairs
Duties: Will report to Assistant General Counsel. Work within the law department?s 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 company's group and its companies. Will provide strategic advice and legal support on a wide variety of domestic and international regulatory, product, research, quality and manufacturing issues. Will be responsible for 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 FDA?s 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 Company?s Policies. Advising the business on product, research, and regulatory requirements in support of international initiatives. Handling special projects as necessary.Estimated Salary: $20 to $28 per hour based on qualifications.
BITSOFT INTERNATIONAL, INC.
Senior Counsel - FDA Regulatory Affairs
Duties: Will report to Assistant General Counsel. Work within the law department?s 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 company's group and its companies. Will provide strategic advice and legal support on a wide variety of domestic and international regulatory, product, research, quality and manufacturing issues. Will be responsible for 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 FDA?s 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 Company?s Policies. Advising the business on product, research, and regulatory requirements in support of international initiatives. Handling special projects as necessary.Estimated Salary: $20 to $28 per hour based on qualifications.
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