Director, Regulatory Affairs Strategy - Cell Therapy
About the job
What you'll do
Lead global regulatory strategy for a complex cell therapy program, including Health Authority interactions, expedited designations, BLA submissions, labeling, and post-approval activities. Partner with global and cross-functional teams to assess emerging data, manage regulatory risks and milestones, and support process improvement and colleague development.
What they're looking for
Requires an advanced degree in a science-related field and typically five to eight years of relevant experience, with broad pharmaceutical regulatory affairs and drug or biologic development knowledge. Candidates should have experience leading regulatory and cross-functional teams and Health Authority interactions, along with strong strategic, communication, organizational, and risk-assessment skills.