Regulatory Program Leader - Postmarket Surveillance and Advocacy
July 30, 2018
Full Time - Experienced
We are currently seeking Regulatory Program Leader – Postmarket Surveillance and Advocacy to join our Regulatory Affairs organization. The position will provide scientific expertise and strategic guidance to a broad spectrum of internal and external stakeholders charged with fulfilling our reduced-risk product strategies.
Altria aspires to be the U.S. leader in authorized, non-combustible, reduced risk products. (Learn more at Altria.com) Our approach to regulatory advocacy relies on deep scientific expertise, understanding of consumer and effective engagement and collaboration with regulatory agencies. Fueled by our strong core tobacco business, we've been concentrating on new product platforms. These include oral nicotine containing products, E-Vapor??, and heated tobacco products?.
We believe these platforms have potential to drive adult smoker conversion. We can only compete in the marketplace with products authorized by the FDA and we can only communicate reduced risk claims with FDA authorization. We plan to file a number of regulatory applications in the coming years.?
As existing products continue to improve, new products become available, and the FDA authorizes manufacturers to communicate accurate risk information, we believe adult smoker conversion will accelerate. This will be a win for adult tobacco consumers, for public health and for our long-term commercial success.
Specific accountabilities include:* Leading the development and execution of scientific strategies and advocacy efforts in support of FDA submissions, external engagements on tobacco regulatory science and postmarket surveillance activities.
Serving as the lead science advocate for specific post-market surveillance activities including annual reporting to support pre-marker tobacco product and modified risk tobacco product post-authorization commitments
Applying knowledge of FDA tobacco regulation, and public health standards in the assessment of the population impact of new tobacco products in support of MRTP/PMTA submissions and postmarket surveillance activities.
Applying quantitative risk assessment principles to address complex regulatory requirements for product submissions.
Collaborating within and across departments or external stakeholders on the development of control measures, prevention programs and mitigation strategies in support of postmarket surveillance infrastructure.
Authoring written materials that translate complex scientific information into sound and persuasive communications
Applying deep scientific expertise and broad understanding of regulatory and business processes, goals and strategies to advance reduced-risk product offerings
Conceptualization and defense of scientific strategy in support of MRTP/PMTA submission in front of Tobacco Product Scientific Advisory Committee (TPSAC)
Participating in meetings with Center for Tobacco Product (CTP) scientists at FDA for discussions related to the science and evidence for product applications and or postmarket surveillance activities
Collaboratively developing study designs and strategies to establish scientific evidence for regulatory submissions in collaboration with cross-functional teams with scientists from various disciplines - clinical research, behavioral research, epidemiology, toxicological sciences, analytical sciences and product development
Independently developing and delivering presentations to other scientists as well as senior management
Coaching and mentoring technical talent
Identifying key opinion leaders in the field and building a network of experts to assure that our approach and execution is accepted within the FDA, public health and scientific communities
Maintaining a high level of technical knowledge within in order to educate and positively influence research requirements within the agreed upon framework Qualifications include:
Terminal Degree (Ph.D, MD) in a related science discipline, such as, but not limited to Epidemiology, Biostatistics, Human Biology, Biomedical Science, Behavioral Pharmacology, or Neuroscience/Addiction
10+ years related professional work experience with a record of achievement and career development
Widely recognized credibility and expertise in a related science discipline, supported by research, publications and presentations to scientific communities
Highly advanced communication skills, both written and verbal, including demonstrated interest and proficiency in public speaking to both large and small groups. The ability to clearly, concisely and confidently explain complex scientific concepts to audiences with deep technical expertise and to those without
Experience in the development of computational models to predict population impacts of an intervention
Regulatory knowledge and experience, including direct engagement with legislative bodies and regulatory agencies (ideally with FDA, CTP)
General knowledge of regulatory requirements for various industries (e.g., tobacco, chemical, etc.)
Aptitude and willingness to learn the tobacco industry and the growth of regulations
Experience in a consumer products industry, ideally pharma or tobacco
Versatility including knowledge and experience in the following key disciplines: Epidemiology, Biostatistics, Population modeling Consumer perception and behavior research, Clinical trial design and execution, Toxicology, and Product Lifecycle.
Innovation and inclusion – uses innovation skills and processes to discover new insights, proactively seeks diverse perspectives and encourages others’ ideas
Advocacy – Skilled in effectively influencing with and more often without direct authority, pushing back appropriately and offering compelling strategies supported by relevant facts and supporting data
Strong analytic and critical thinking skills; ability to analyze and synthesize data, develop data-driven conclusions and insights, and deliver them in engaging presentations or publishable reports
Experience heading diverse teams, collaboratively planning and executing large scale initiatives, setting goals, developing and motivating direct and indirect reports, and resolving conflicts
Ability to occasionally travel domestically and internationally 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.