Regulatory Affairs Consultant
1 week ago
Parexel 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 regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.
Ideal candidate will possess:
University degree in life science discipline
Significant CRO/Pharma experience within Regulatory
Solid analysis and synthesis capability; Solution-oriented and problem-solving skills
Fluency in English is a must along with the local language
A background in clinical trial submissions with a specific focus on EU-CTR
Project Management experience
Fluent English and local language
- Other
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Regulatory Affairs Consultant
4 weeks 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
4 weeks 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
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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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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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Regulatory Affairs Consultant
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King of Prussia, United States Parexel International Corporation Full time1. 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...
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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
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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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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
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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.