Company description:
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Primary representative for EU (EU, UK, Switzerland (CH), Australia (AUS), New Zealand (NZ) regulatory strategy for the Oncology Therapeutic Area GYN/GI/Melanoma and Breast
Oversee/contribute to development of EU regional strategies for the Oncology designated TA as a member of Global Regulatory Strategic Team (GRST).
Lead, oversee, implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products, in line with commercial goals.
Supervise EU regulatory strategists, accountable for staff + talent management
Ensure timely submissions + approvals with commercially attractive labeling in EU.
Ensure optimal regulatory interactions with EU Health Authorities for programs.
Contribute to the Regulatory Strategy Leadership Team; drive required culture and behaviors.
QUALIFICATIONS
Advanced Scientific Degree (M.D, Ph.D, Pharm.D, M.Sc). or equivalent experience in drug, device, development and/or commercialization & Knowledge of oncology therapeutic area
Proven business management capabilities
Demonstrable experience in drug and/or device development or relevant experience in the pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally in Regulatory Sciences/Health& Authority and/or proven track record of success in negotiating with Health Authorities at EU regiona...