Director Regulatory Engagement, Sr Principal Scientist
May 22, 2018
Full Time - Experienced
Quality/Risk Management, Regulatory Compliance
We are currently seeking a Director Regulatory Engagement, Senior Principal Scientist in our Regulatory Sciences area. This position will report to the VP of Regulatory Sciences and is responsible for leading proactive internal and external scientific engagement and communication strategies. This position will translate and communicate science-based solutions that advance business goals, inform regulatory and scientific direction/strategies and increase probability of obtaining FDA market approvals.
Specific accountabilities include:
Translating scientific discoveries, regulatory policies, and market needs into regulatory and scientific communication strategies that lead to new category growth and enhanced speed to market for new products.
Leading the utilization of scientific and regulatory insights to enable internal functions to have greater transparency, accountability and deliver higher quality results that support business goals.
Developing engagement strategies with regulators (e.g., through active participation in conferences and industry / agency regulatory meetings, committees and scientific associations).
Developing strategic collaborations, workshops and communications with Public Health thought leaders on Tobacco Harm Reduction.
Developing scientific and regulatory publication strategies that support Tobacco Harm Reduction.
Utilizing scientific and regulatory insights to ensure that reduced risk claims align with consumer behavior, current scientific knowledge and regulations.
Utilizing scientific and regulatory insights to ensure that new product and project risks are appropriately addressed and communicated to relevant stakeholders.
MS or Ph.D. in Public Health or a related science discipline.
12+ years' experience in regulated industry (including as FDA liaison)
Full functional knowledge of the regulatory requirements pertaining to tobacco
Successful submission, approval and post-approval management of an NDA/MAA
Strong project management skills
Experience with product development 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, John Middleton and Nu Mark. The companies’ brands include Marlboro, Copenhagen, Skoal, Black & Mild, MarkTen and VERVE. Altria also owns Ste. Michelle Wine Estates, one of the country’s top premium wine producers, and Philip Morris Capital Corporation, an investment company. Altria’s 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 help Altria Group and its operating companies responsibly meet their business goals by providing the high quality services they require in a financially disciplined way. 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.
Each Altria company is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class.