about 1 year ago
Responsible for developing and implementing global regulatory strategies including clinical, non-clinical and CMC disciplines.
Mentor other regulatory professionals working on the project team and regulatory process-related subjects.
Work both independently and with a team.
Prepare and manage submissions. Substantial. interaction with departments outside of regulatory affairs.
Contributes to global clinical, regulatory plans, and strategies. Will identify and propose risk mitigation strategies. Influences project teams internationally.
Required experience in filing regulatory documents including CTAs, IMPDs, INDs. Experience with BLAs/NDAs/MAAs is helpful.