Global Regulatory Affairs Lead

hace 7 días

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

We are seeking a highly skilled and experienced Global Regulatory Affairs Lead to join our team at Sobi - Swedish Orphan Biovitrum AB (publ). As a key member of our organization, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulatory requirements.

Key Responsibilities
  • Develop and implement global regulatory strategies for assigned programs, including risk assessment and mitigation strategies.
  • Provide global regulatory leadership and guidance to cross-functional teams, including Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, and Global Medical & Scientific Affairs.
  • Champion the use of expedited regulatory pathways globally to accelerate patients' access to life-saving treatments.
  • Represent Sobi in major/critical regulatory Agency meetings, including the US FDA, EMA/CHMP, PMDA, and NMPA/CDE.
  • Collaborate with regulatory authorities, partners, and consultants to ensure compliance with regulatory requirements.
  • Participate in strategic and regulatory evaluations of in-licensing matters and provide recommendations for approval.
  • May have direct oversight/management of Regulatory Affairs team members supporting assigned programs.
Requirements
  • Degree in Life Sciences.
  • Expert knowledge of all Regulatory Affairs processes, applications, and regulatory environments to achieve and maintain marketing authorizations.
  • Good knowledge of drug development and the rare diseases regulatory environment.
  • Experience in haematology is preferred.
  • Very good knowledge in written and oral English, knowledge of other languages is an upside but not required.
About Sobi

Sobi is a global company with over 1,700 employees in more than 30 countries, committed to the societies where we operate. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our Culture

We refuse to accept the status quo and have witnessed first-hand the challenges facing those affected by rare diseases. We have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases and see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits 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 or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans, and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

  • Global Regulatory Affairs Lead

    hace 3 días

    Madrid, Madrid, España Sobi Group A tiempo completo

    **Job Summary**Sobi Group is seeking a highly skilled Global Regulatory Affairs Lead to join our team. As a key member of our organization, you will be responsible for providing global regulatory leadership and strategic direction for assigned programs.**Key Responsibilities:**Serve as the single point of contact for regulatory matters within the Global...

  • Global Regulatory Affairs Lead

    hace 4 días

    Madrid, Madrid, España Sobi Group A tiempo completo

    **Job Summary**Sobi Group is seeking a highly skilled Global Regulatory Affairs Lead to join our team. As a key member of our organization, you will be responsible for providing global regulatory leadership and strategic direction for assigned programs.**Key Responsibilities:**Serve as the single point of contact for regulatory matters within the Global...

  • Global Regulatory Affairs Lead

    hace 7 días

    Madrid, Madrid, España Sobi Group A tiempo completo

    Job SummarySobi Group is seeking a highly skilled Global Regulatory Affairs Lead to join our team. As a key member of our organization, you will be responsible for providing global regulatory leadership and strategic direction for our rare disease programs.Key Responsibilities:Serve as the single point of contact for global regulatory matters, working...

  • Global Regulatory Affairs Lead

    hace 6 días

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

    About the RoleSobi, a global biopharmaceutical company, is seeking a highly skilled Global Regulatory Affairs Lead to join our team. As a key member of our organization, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulatory requirements.Key ResponsibilitiesDevelop and implement global regulatory...

  • Global Regulatory Affairs Lead

    hace 7 días

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

    About the RoleSobi, a global biopharmaceutical company, is seeking a highly skilled Global Regulatory Affairs Lead to join our team. As a key member of our organization, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulatory requirements.Key ResponsibilitiesDevelop and implement global regulatory...

  • Global Regulatory Affairs Lead

    hace 1 día

    Madrid, Madrid, España Sobi Group A tiempo completo

    Job DescriptionKey Responsibilities:Serve as the single point of contact and accountability within the Global Regulatory Affairs team for assigned programs, collaborating closely with the Core Asset Team and Medicines Development Team.Chair the Global Regulatory Team, comprising regulatory subject matter experts, to provide strategic guidance and oversight...

  • Global Regulatory Affairs Lead

    hace 22 horas

    Madrid, Madrid, España Sobi Group A tiempo completo

    Job DescriptionKey Responsibilities:Serve as the single point of contact and accountability within the Global Regulatory Affairs team for assigned programs, collaborating closely with the Core Asset Team and Medicines Development Team.Chair the Global Regulatory Team, comprising regulatory subject matter experts, to provide strategic guidance and oversight...

  • Global Regulatory Affairs Lead

    hace 7 días

    Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Lead to join our team at Sobi Group. As a key member of our organization, you will be responsible for providing strategic regulatory leadership for our rare disease therapies.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement global regulatory strategies to...

  • Global Regulatory Affairs Lead

    hace 6 días

    Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Lead to join our team at Sobi Group. As a key member of our organization, you will be responsible for providing strategic regulatory leadership for our rare disease therapies.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement global regulatory strategies to...

  • Global Regulatory Affairs Lead

    hace 2 días

    Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job DescriptionKey Responsibilities and Accountabilities:In this critical role, you will serve as the single point of contact and accountability within the Global Regulatory Affairs team for assigned programs. Your key responsibilities will include:Global Regulatory Leadership: Provide strategic guidance and oversight to ensure compliance with regulatory...

  • Global Regulatory Affairs Lead

    hace 2 días

    Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job DescriptionKey Responsibilities and Accountabilities:In this critical role, you will serve as the single point of contact and accountability within the Global Regulatory Affairs team for assigned programs. Your key responsibilities will include:Global Regulatory Leadership: Provide strategic guidance and oversight to ensure compliance with regulatory...

  • Regulatory Affairs Director

    hace 2 días

    Madrid Centro, Madrid, España Innovaderm Research A tiempo completo

    Job SummaryThe Senior Manager, Regulatory Affairs will be responsible for overseeing the regional regulatory affairs department at Innovaderm Research, ensuring that all services are conducted in accordance with the company's standard operating procedures, applicable regulations, and good clinical practices.Key ResponsibilitiesLeadership and Strategic...

  • Regulatory Affairs Director

    hace 3 días

    Madrid Centro, Madrid, España Innovaderm Research A tiempo completo

    Job SummaryThe Senior Manager, Regulatory Affairs will be responsible for overseeing the regional regulatory affairs department at Innovaderm Research, ensuring that all services are conducted in accordance with the company's standard operating procedures, applicable regulations, and good clinical practices.Key ResponsibilitiesLeadership and Strategic...

  • Regulatory Affairs Director

    hace 2 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    Job DescriptionJob Title: Regulatory Affairs DirectorJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Develop and...

  • Regulatory Affairs Director

    hace 2 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    Job DescriptionJob Title: Regulatory Affairs DirectorJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Develop and...

  • Regulatory Affairs Manager

    hace 7 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    Job DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...

  • Regulatory Affairs Manager

    hace 6 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    Job DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...

  • Regulatory Affairs Manager

    hace 6 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable regulations, and good clinical...

  • Regulatory Affairs Manager

    hace 7 días

    Madrid, Madrid, España Innovaderm Research A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable regulations, and good clinical...

  • Regulatory Affairs Specialist

    hace 2 días

    Madrid Centro, Madrid, España Elanco A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Elanco. As a key member of our regulatory team, you will play a critical role in ensuring the successful development and approval of our animal health products.Key ResponsibilitiesDevelop and Implement Regulatory StrategiesDevelop and implement global regulatory...