The PDP will support product evaluation, registrations and navigating authority enquiries for food and drug product with a primary focus on India, China and Japan markets. The PDP will participate in regulatory strategy development, requirement gathering and data reviews for a new product in development or sourcing programs. The PDP will collaborate across Regulatory Affairs team to help define and drive the “standard work” concept.
The PDP will be responsible for gathering and learning regulatory requirements, preparing, and reviewing regulatory submissions, reviewing data records, applying knowledge to effectively present technical data in regulatory submissions; responsible for reviewing department procedures and proposing updates in alignment with regulations as well as creating new procedures as needed.