Regulatory Affairs Director
Core
Lead European regulatory strategy for oncology medicines to secure rapid approvals and competitive labeling across Europe.
Role type
Senior Regulatory Affairs Director (Oncology)
Builds
Oncology drug products for European markets
Domain
Pharmaceutical / Oncology
Deliverable
client delivery
Required skills
European regulatory strategy, MAA and variation submissions, EMA engagement, global regulatory alignment, risk assessment, Phase 3 design, product maintenance
Preferred skills
Phase 3 design experience, major Health Authority interactions, labeling negotiations, small molecules and biologics experience
Technologies
None stated
Responsibilities
Own and deliver European regulatory strategy for assigned oncology products; Serve as the face of AstraZeneca with the EMA and other European authorities; Lead MAA and variation submissions; Lead the Global Regulatory Strategy Team for early-stage projects; Provide strategic regulatory advice to Global Product Teams; Shape strategy for new indications and novel combinations; Objectively assess emerging data against program aspirations; Lead product maintenance activities for marketed brands; Engage with regional affiliates and trade organizations
Seniority
Senior, strategic leadership