Regulatory Study Lead
We are currently seeking a highly qualified Principal Scientist to join our Regulatory Sciences department in Richmond, VA. The successful candidate will lead the development and execution of scientific studies (chemistry and physical testing) and communicate complex scientific information in clear and compliant written communications to ensure successful preparation of high quality documents for FDA product applications and submissions.
Specific accountabilities include:
- Coordinating with various subject matter experts to develop and execute chemistry, stability and physical testing studies on products for regulatory applications and submissions primarily to the FDA.
- Assessing data on products and processes for regulatory applications and submissions, primarily to the FDA.
- Developing clear and effective communications of scientific information from chemistry, stability and physical testing studies for FDA regulatory applications and submissions.
- Overseeing third party communication of scientific information for FDA regulatory applications and submissions.
- Independently conducting comprehensive literature searches and reviewing and analyzing relevant literature to summarize appropriately for FDA regulatory applications and submissions.
- Conducting scientific/technical review of material prepared by other scientists to include abstracts, protocols and study reports.
- External engagement and study leadership requiring domestic/international travel.
- A Bachelor's degree in chemistry plus a minimum of 8 years of relevant experience, including chemistry study leadership and writing for FDA submissions and applications. Masters or PhD is preferred.
- Scientific writing experience; experience preparing Investigational New Drug (IND), New Drug Application (NDA), Premarket Approval (PMA) or Premarket Tobacco Approval (PMTA) submissions preferred.
- Excellent interpersonal, analytical and critical thinking skills.
- Strong project management and organizational skills and proven ability to meet timelines.
- Strong communication stills, proficient command of the English language in both oral and written format, and action orientation to address issues.
- Proficient with Microsoft Office applications, Adobe Acrobat, Reference Manager and other related technology tools.
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.
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.
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