Regulatory Affairs Specialist
3 days ago
We are seeking 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.
Key Responsibilities:- Provide leadership in all regulatory and submissions related aspects of the clinical trial
- Deliver submission specific milestones and provide guidance to the client on submissions strategies
- Collaborate with departments to ensure transversal collaboration and delivery of all submissions of complex large clinical trials
- 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 and local language
- Background in clinical trial submissions with a specific focus on EU-CTR
- Project Management experience
Parexel Croatia is a leading provider of clinical trials services, and we are committed to delivering high-quality solutions to our clients. If you are a motivated and experienced Regulatory Affairs Consultant, we encourage you to apply for this exciting opportunity.
-
Regulatory Affairs Specialist
2 days ago
King of Prussia, Pennsylvania, United States PAREXEL Full timeParexel Croatia is seeking an experienced Regulatory Affairs Specialist to provide operational and business clinical trials regulatory consultancy to clients. The ideal candidate will possess a university degree in a life science discipline, significant CRO/Pharma experience within Regulatory, and fluency in English and the local language. Key...
-
Regulatory Affairs Policy Specialist
4 days ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Policy Specialist to join our team at Exelixis. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform our policy and practices.Key ResponsibilitiesMonitor the external regulatory environment to identify emerging intelligence with...
-
Regulatory Affairs Policy Specialist
3 weeks ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Policy Specialist to join our team at Exelixis. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices.Key ResponsibilitiesMonitor the external regulatory environment to identify emerging intelligence with...
-
Regulatory Affairs Specialist
3 days ago
King of Prussia, Pennsylvania, United States Parexel International Corporation Full timeRegulatory Affairs ProfessionalWe are seeking an experienced Regulatory Affairs Professional to join our team at Parexel International Corporation. In this role, you will be responsible for managing clinical trial submissions and coordinating regulatory affairs across various countries.Key Responsibilities:Manage local submissions as Local Regulatory Contact...
-
Regulatory Affairs Policy Specialist
2 days ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob Summary:Exelixis is seeking a highly skilled Regulatory Affairs Policy Specialist to join our team. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices. This includes ensuring timely preparation and completion of action plans to maintain Exelixis processes and...
-
Senior Regulatory Affairs Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States PAREXEL Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team in Romania. This role can be based in our office in Bucharest or worked remotely from home.As a Senior Regulatory Affairs Associate, you will have a few years of experience in Regulatory Affairs gained in the industry. You will bring expertise in Clinical Trial...
-
Regulatory Affairs Specialist
3 days ago
King of Prussia, Pennsylvania, United States Parexel International Corporation Full timeParexel International Corporation is seeking a skilled Regulatory Affairs Consultant to join our team.Key Responsibilities:1. NDA and PMDA Submissions:* Prepare and submit NDA and PMDA applications to regulatory authorities.2. Regulatory Compliance:* Ensure compliance with regulatory requirements and guidelines.3. Document Control:* Maintain accurate and...
-
Regulatory Affairs Specialist
3 days ago
King of Prussia, Pennsylvania, United States Parexel International Corporation Full timeParexel International Corporation Job OpportunityWe are seeking 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...
-
Regulatory Affairs Director
3 days ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Exelixis. As a key member of our Commercial Regulatory Affairs team, you will be responsible for providing strategic regulatory leadership and oversight for promotional initiatives and activities.Key ResponsibilitiesEnsure compliance with FDA regulations for...
-
Regulatory Affairs Director
3 days ago
King of Prussia, Pennsylvania, United States Exelixis Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Exelixis. As a key member of our Commercial Regulatory Affairs team, you will be responsible for providing strategic regulatory leadership and ensuring compliance with all FDA regulations for prescription drug, advertising, and promotions.Key ResponsibilitiesDevelop...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeAbout the RoleCSL Behring is seeking a seasoned Communications professional to join our team as a Senior Communications Specialist, ABC and Medical Affairs. This is an exciting opportunity to build and execute communications strategies that drive business objectives and shape the market in accordance with our efforts to serve patients with innovative...
-
Vice President of Medical Affairs
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryCareer Opportunity: Vice President of Medical AffairsCSL Behring is seeking a highly experienced and skilled Vice President of Medical Affairs to provide strategic medical leadership across all CSL products, pipeline, and inline. This critical role will drive medical strategy and execution excellence, enabling R&D strategy and commercial growth...
-
Vice President of Medical Affairs
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This critical role will drive medical strategy and execution excellence, enabling R&D strategy and commercial growth objectives through evidence generation, thought leadership, scientific engagement, and product...
-
Senior Director, Head of Medical Affairs, Latam
2 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob Title: Senior Director, Head of Medical Affairs, LatamThe Senior Director, Head of Medical Affairs, LatAm & Partner Business will provide strategic, operational, and medical leadership for a high-performance Medical Affairs organization across the CSL Behring responsible cluster, supporting ~$0.9B in revenue. This is a critical role to drive medical...
-
Regulatory Affairs Specialist
18 hours ago
King of Prussia, Pennsylvania, United States Parexel International Corporation Full timeParexel International Corporation busca um especialista em questões regulatórias para trabalhar em projetos de desenvolvimento de medicamentos e dispositivos médicos. O candidato deve ter experiência em revisão de documentos e procedimentos de registro de produtos.Responsabilidades:Revisar e atualizar procedimentos de registro de produtos;Trabalhar em...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Senior Director, Head of Medical Affairs, Latam will provide strategic, operational, and medical leadership for a high-performance Medical Affairs organization across the CSL Behring responsible cluster, supporting ~$0.9B in revenue.Main ResponsibilitiesOversee and direct responsible cluster, Lead Medical Directors' activities in developing...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Senior Director, Head of Medical Affairs, LatAm & Partner Business will provide strategic, operational, and medical leadership for a high-performance Medical Affairs organization across the CSL Behring responsible cluster, supporting ~$0.9B in revenue. This is a critical role to drive medical strategy and execution excellence for a critical...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob Title: Senior Director, Medical Affairs, Inline BleedingCSL Behring is seeking a highly skilled and experienced Senior Director, Medical Affairs, Inline Bleeding to provide strategic medical leadership across all inline bleeding products. This critical role will drive medical strategy and execution excellence, enabling commercial growth objectives...
-
Senior Director, Medical Affairs, Hemostasis
3 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeSenior Director, Medical Affairs, Inline BleedingCSL Behring is seeking a highly experienced Senior Director, Medical Affairs, Inline Bleeding to provide strategic medical leadership across all inline bleeding products. This critical role will drive medical strategy and execution excellence, enabling commercial growth objectives through evidence generation,...
-
Senior Director, Medical Affairs, Ig Products
2 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Senior Director, Medical Affairs, Inline Ig will provide strategic medical leadership across all inline Ig products. This is a critical role to drive medical strategy and execution excellence, enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement, and product expertise.Main...