Regulatory Procedural Management and Clinical Trial Lead
vor 3 Wochen
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to making a positive impact on the lives of people around the world.
About the Role
We are seeking a highly qualified and experienced Regulatory Procedural Management and Clinical Trial Lead to join our team in Europe. As a key member of our Regulatory Affairs team, you will be responsible for providing regulatory leadership, guidance, and project management to assigned projects in a manner that is scientifically sound, commercially viable, and in accordance with regulatory standards.
Key Responsibilities
- Lead the Regulatory Procedural Procedure & Project Management team in the EU & AMELA, serving as a link between Regulatory Strategists and other disciplines inside RA and in R&D and in the business units.
- Provide managerial and regulatory procedural guidance and operational strategy for development projects and marketed products in the EU & AMELA.
- Mentor and instruct internal and external (in-)direct reports, including members of the consultants and vendors, and plan, assign, and direct work.
- Lead assigned non-project tasks designed to enhance the functionality and processes of RA.
Requirements
- Deep knowledge of Global and European laws, regulations, guidelines in EU, US, and Japan, and other requirements for human medicinal product marketing authorization and maintenance.
- Working experience in pharmaceutical industry, in Clinical Research Organizations, or in a regulatory authority with at least 10 years of experience in regulatory affairs.
- Excellent interpersonal leadership and communication skills, with the ability to communicate and work across functions effectively in a multinational organization.
- Computer proficiency, including MS Office, document management systems, and databases.
Why Work with Us?
At Daiichi Sankyo Europe, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic and challenging work environment, with opportunities for growth and development. If you have a proactive mindset and passion for addressing the needs of patients, we encourage you to apply for this exciting opportunity.
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Regulatory Procedural Management and Clinical Trial LeadWe are seeking a highly qualified candidate to fill the position of Regulatory Procedural Management and Clinical Trial Lead at Daiichi Sankyo Europe. As a key member of our Regulatory Affairs team, you will be responsible for providing regulatory leadership, guidance, and project management...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Regulatory Procedural Management and Clinical Trial LeadWe are seeking a highly qualified candidate to fill the position of Regulatory Procedural Management and Clinical Trial Lead at Daiichi Sankyo Europe. As a key member of our Regulatory Affairs team, you will be responsible for providing regulatory leadership, guidance, and project management...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJoin Our Team as a Regulatory Procedural Management and Clinical Trial LeadAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we are committed to...
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