Regulatory Manager - 100% REMOTE

Position Summary:
Regulatory Affairs Associate Manager/ Manager that will be responsible for supporting the development of submission strategy and health authority responses for assigned studies and the review of regulatory documents/applications under the direction of the Regulatory Affairs Lead, in compliance with guidelines and regulations. The contractor should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment.
Position Responsibilities:
● Help support responses to health authority request for information or queries
● Review of regulatory documents including but not limited to Protocol, IB, DSUR, IMPD.
● Active participation in global regulatory project team (GRPT) and the clinical strategy team (CST).
● Work closely with the Regulatory Affairs Lead and cross-functional team members to support the regulatory activities in the pipeline ...