Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs (RA) Specialist, will manage and lead regulatory submissions and develop regulatory strategies for investigational and marketed products by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on CMC and will also include clinical and non-clinical submission. This position serves as the regulatory representative on relevant project teams and as the regulatory contact with health authorities.

Actively understand and interpret industry trends and health authority's expectations in areas related to CMC, non-clinical and clinical. Influence and communicate how these trends align with strategic department direction and vision.