Global Regulatory Affairs Lead

hace 2 semanas

Madrid, Madrid, España Sobi - Swedish Orphan Biovitrum AB (publ) A tiempo completo
About Sobi

Sobi is a global biopharmaceutical company dedicated to rare diseases. We strive to make a positive impact on the lives of patients and their families. Our mission is to develop and deliver innovative therapies that improve the lives of those affected by rare diseases.

Job Description

Key Responsibilities:

  • Provide global regulatory leadership for assigned programs, developing strategies to ensure compliance and expedited regulatory pathways.
  • Chair the Global Regulatory Team and collaborate with regulatory authorities, partners, and stakeholders to achieve business objectives.
  • Develop and maintain relationships with key regulatory agencies, including the US FDA, EMA, and PMDA.
  • Participate in strategic evaluations of in-licensing matters and provide regulatory expertise to support business decisions.
  • Lead and manage Regulatory Affairs team members supporting assigned programs.

Requirements:

  • Degree in Life Sciences
  • Expertise in Regulatory Affairs processes, applications, and regulatory environment
  • Good knowledge of drug development and rare diseases regulatory environment
  • Experience in haematology is preferred
  • Very good knowledge in written and oral English

Why Sobi?

We are a global company with over 1,700 employees in more than 30 countries. We are committed to the societies where we operate and strive to make a positive impact on the lives of patients and their families. Our culture conveys that our employees are our most valuable asset, and we offer a competitive benefits package to support their health and happiness.

We are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, national origin, sex, age, disability, HIV status, sexual orientation, gender identity, protected veterans, or any other status or protected groups by the laws or regulations in the locations where we operate.

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