Company description: FOR THE FULL JD PLEASE VISIT OUR PFIZER UK CAREERS WEBPAGE. 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 regional level and in representing interests to internal and external stakeholders Relevant Global regulatory experience (more than 1 region) Demonstrated strategic thinking; integrate strategies into actionable plans Function autonomously at a senior level in a highly matrixed organization Significant experience of oncology therapeutic area, prior regulatory experience; direct product development and/or academic training Prove ability to develop & implement regulatory strategy - Understand regulatory agency. philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs/MAA/IRDs. Working with/influencing regulators and opinion leaders, facilitate approval of submissions with labeling meeting corporate expectations Excellent at communicating and presenting complex information / analyses in various formats to varied audiences Location: Walton Oaks (Surrey) or Sandwich (Kent) with hybrid working options. Job description: FOR THE FULL JD PLEASE VISIT OUR PFIZER UK CAREERS WEBPAGE. 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 regional level and in representing interests to internal and external stakeholders Relevant Global regulatory experience (more than 1 region) Demonstrated strategic thinking; integrate strategies into actionable plans Function autonomously at a senior level in a highly matrixed organization Significant experience of oncology therapeutic area, prior regulatory experience; direct product development and/or academic training Prove ability to develop & implement regulatory strategy - Understand regulatory agency. philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs/MAA/IRDs. Working with/influencing regulators and opinion leaders, facilitate approval of submissions with labeling meeting corporate expectations Excellent at communicating and presenting complex information / analyses in various formats to varied audiences Required profile: Exciting opportunity alert We are looking for an EU TA Lead for GYN/GI/CRC/Breast to join our team. This role is pivotal in shaping the regulatory strategy for Oncology across the EU, UK, Switzerland, Australia, and New Zealand. As a key member of the Global Regulatory Strategic Team, you will oversee and implement EU regulatory strategies, ensuring timely submissions and approvals, and fostering optimal interactions with EU Health Authorities. If you have an advanced scientific degree, extensive experience in drug development or clinical research, and a proven track record in regulatory strategy, we want to hear from you Join us in driving innovation and excellence in the Oncology Therapeutic Area. ?? Location: Walton Oaks (Surrey) or Sandwich (Kent) with hybrid working options. Apply now and be part of a dynamic team making a difference in the field of Oncology Go to our company careers page for details & to apply directly. What we offer: Exciting opportunity alert We are looking for an EU TA Lead for GYN/GI/CRC/Breast to join our team. This role is pivotal in shaping the regulatory strategy for Oncology across the EU, UK, Switzerland, Australia, and New Zealand. As a key member of the Global Regulatory Strategic Team, you will oversee and implement EU regulatory strategies, ensuring timely submissions and approvals, and fostering optimal interactions with EU Health Authorities. If you have an advanced scientific degree, extensive experience in drug development or clinical research, and a proven track record in regulatory strategy, we want to hear from you Join us in driving innovation and excellence in the Oncology Therapeutic Area. ?? Location: Walton Oaks (Surrey) or Sandwich (Kent) with hybrid working options. Apply now and be part of a dynamic team making a difference in the field of Oncology Go to our company careers page for details & to apply directly. ADZN1_UKTJ