The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) aspects of projects in clinical phase through initial product registration and post approval life cycle management for the assigned portfolio of small molecule or biologic products.
The Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis.
The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners in support of project execution.