The Regulatory Specialist is responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable drug regulations, guidance, and standards (US/North America). Assist in creation and maintenance of regulatory files.

Key Responsibilities:

• Write, analyze, and edit technical documents to support regulatory submissions and compile submissions, including IND and NDA submissions in the USA. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
• Maintain regulatory files. Maintain and update regulatory documents, such as INDs and NDAs. Assure that appropriate maintenance of registrations occurs including renewals, drug listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required.
• Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
• Perform as a member of the Change Control Board to identify regulatory impact and required regulatory reporting/submission for proposed changes.
• Other duties as assigned.