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Senior EU Regulatory Strategy Lead

2 mesi fa


Milano, Lombardia, Italia Tn Italy A tempo pieno
About the Role

We are seeking a highly experienced and skilled Senior EU Regulatory Strategy Lead to join our team at Tn Italy. As a key member of our Global Regulatory Strategic Team, you will be responsible for developing and implementing EU regional strategies for our designated early phase Oncology portfolio.

Key Responsibilities
  • Develop and oversee EU regional strategies for the designated early phase Oncology portfolio, in line with commercial goals and in collaboration with key stakeholders.
  • Lead and implement EU regulatory strategies for assigned projects/products, ensuring timely submissions and approvals in the EU.
  • Supervise EU regulatory strategists and be accountable for staff and talent development, career development and planning, and performance management.
  • Ensure optimal regulatory interactions with EU Health Authorities for programs in the designated early phase Oncology portfolio.
  • Contribute to the EU Oncology Regulatory Strategy Leadership Team and drive the required culture and behaviors through the organization.
  • Champion flexible approaches to ensure efficient and effective resource utilization.
Requirements
  • Advanced scientific degree (M.D, Ph.D, Pharm.D, M.Sc) or equivalent experience in drug, device, development, and/or commercialization.
  • Business qualification (MBA) may be useful.
  • Proven business management capabilities and demonstrable experience in drug and/or device development or relevant experience in the Pharmaceutical industry.
  • Relevant global regulatory experience (more than one region) and demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Proven ability to function autonomously at a senior level in a highly matrixed organization and significant experience of the oncology therapeutic area.
  • Proven ability in developing and implementing regulatory strategy, understanding of regulatory agency philosophy and guidelines, and experience preparing and submitting CTAs, MAA.
  • Excellent communication and presentation skills, with the ability to communicate complex information and analyses to a variety of scientific audiences.
  • Negotiation skills, with the ability to negotiate skillfully in tough situations with both internal and external groups.
About Tn Italy

Tn Italy is a patient-centric company, guided by our four values: courage, joy, equity, and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. We aim to create a trusting, flexible workplace culture which encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self. We believe that a diverse and inclusive workforce is crucial to building a successful business and are committed to celebrating this in all its forms.