Regulatory Affairs Consultant
2 weeks ago
1. Should have experience in eCTD, NeeS and paper formats.
2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met.
4.Should have experience in handling submission gateway sites.
Experience- 5-8 yrs
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Regulatory Affairs Consultant
1 week ago
King Of Prussia, United States Parexel International Corporation Full timeRegulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely...
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Regulatory Affairs Consultant
1 week ago
King of Prussia, United States Parexel International Corporation Full timeParexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe.In this role you will provide leadership in all...
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Senior Regulatory Affairs Associate
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King of Prussia, United States PAREXEL Full timeSenior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization...
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Senior Regulatory Affairs Associate
2 weeks ago
King of Prussia, United States PAREXEL Full timeWe are looking for aSenior Regulatory Affairs Associate to join our growing team in Romania.This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various...
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Regulatory Affairs Professional
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King of Prussia, United States Parexel International Corporation Full timeWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote.Key Deliverables in the role:Manage the local...
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Regulatory Affairs Professional
4 weeks ago
King of Prussia, United States Parexel International Corporation Full timeWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote.Key Deliverables in the role:Manage the local...
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King of Prussia, Pennsylvania, United States Parexel International Corporation Full timeWe are seeking a Senior Regulatory Affairs Associate to join our team in Romania. This role can be either home or office based in Bucharest.As a Senior Regulatory Affairs Associate, you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trial Applications (CTA) from various European...
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Senior Regulatory Affairs Associate
1 week ago
King of Prussia, United States Parexel International Corporation Full timeWe are looking for aSenior Regulatory Affairs Associate to join our growing team in Romania.This role can be either home or office based in Bucharest.As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various...
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Regulatory Affairs Consultant
1 week ago
King of Prussia, PA, United States Parexel International Corporation Full timeParexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe.In this role you will provide leadership in all...
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King of Prussia, United States CSL Behring Full timeDirector, Global Regulatory Affairs - North AmericaCareer Opportunities at CSL Behring.We are committed to delivering medicines that improve the lives of millions of people worldwide. With operations in 35+ nations and ~ 30,000 employees globally, we are a global leader in protein biotherapeutics.About the Job:This role will be based in our King of Prussia,...
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Senior Regulatory Affairs Associate
1 week ago
King of Prussia, PA, United States Parexel International Corporation Full timeSenior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization...
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King of Prussia, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
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King of Prussia, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
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King of Prussia, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
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King of Prussia, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
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Regulatory Affairs Professional
1 week ago
King of Prussia, PA, United States Parexel International Corporation Full timeWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote.Key Deliverables in the role:Manage the local...
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Senior Regulatory Affairs Associate
1 week ago
King Of Prussia, United States Parexel International Corporation Full timeSenior Regulatory Affairs AssociateExperience: Biologic CMC5+ years of experienceSupported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to:- new application, post approval variations- Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation...
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King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryCSL Behring is a global biotechnology leader seeking an experienced Senior Regulatory Affairs Director to join our North America team.
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Senior Regulatory Affairs Associate
1 week ago
King of Prussia, PA, United States Parexel International Corporation Full timeWe are recruiting for a French Speaking Senior Regulatory Affairs Associate in Europe. We can consider candidates based in Romania, Poland, Lithuania or UK, it is essential that you have fluent French and English language skills and strong CTA experience.This Senior Regulatory Affairs Associate- CTA will support CTA submissionsfor the following...
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Global Regulatory Affairs Director
1 week ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeAbout the RoleWe are seeking an experienced Associate Director to lead our Global Regulatory Affairs team in the North America region. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies that ensure compliance with US FDA regulations and support the successful development and commercialization of...