The Regulatory Affairs Professional (Director) will be responsible for the comprehensive management of regulatory aspects of the company’s development projects while actively contributing as a member of the project team(s). This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.
Duties and Responsibilities
• Responsible for working with the project team to identify an optimum regulatory strategy for assigned projects. Able to lead teams in examining regulatory strategy options.
• Expected to independently interact with regulatory authorities, and outside consultants when needed. Able to independently prepare and lead a team through a regulatory meeting exercise.
• Able to write, review and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
• Supervises and provides guidance to other regulatory personnel as assigned.
• Education: Minimum Bachelor’s degree; studies in science and advanced degree desirable
• Specialized knowledge that would be desirable and supportive of success in this position includes:
o Experience working on promotional materials and with OPDP (formerly DDMAC).
o Experience with US and international management of post-marketing CMC changes
o Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
o Experience in the management of core labeling and/or US labeling
o Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
o Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
o Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
• Experience: Minimum 10+ years progressive Regulatory Affairs or relevant experience