Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports.
Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications.
Communicates with agencies and attending agency meetings to assist the Global Liaison.
Participates as an active member on the Global Regulatory Team.
Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy.
Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment).
Supports maintenance (e.g., quality compliance and life cycle management) of VID programs.
Supports of Global Liaison in label development.
Assists with process improvement initiatives.
Performs regulatory administrative activities as needed.

M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline.
Other degrees such as master's or bachelor’s with experience to suggest equivalent ability to function in this position.
M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master’s degree with at least 3 years of relevant experience in pharmaceutical industry, or Bachelor’s degree with at least 6 years of relevant experience in the pharmaceutical industry
Excellent communication skills (both oral and written).
Good organizational skills with a proven ability to simultaneously balance activities or multiple projects.
Flexibility required.
Strong scientific and analytical skills with attention to detail.

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Associate Principal Scientist – Regulatory Liaison

Key skills