Regulatory Affairs Specialist

Parexel 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...

Job 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...

Job 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 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...

Job SummaryPAREXEL is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the timely performance of work within a project scope to the quality expectations of PAREXEL and our clients.Key ResponsibilitiesManage and coordinate the local regulatory submission strategy...

Job 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 ResponsibilitiesEnsures timely preparation and completion of action plans to maintain Exelixis...

Job 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...

Parexel Croatia 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.Key Responsibilities:Provide leadership in...

Parexel 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...

Parexel 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...

Job 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...

Job 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...

Job SummaryWe are seeking a highly experienced and skilled Senior Director, Commercial Regulatory Affairs to join our team at Exelixis. This role will be responsible for providing strategic regulatory leadership in the areas of advertising and promotion, ensuring compliance with all FDA regulations, and providing regulatory guidance on the review and...

The Senior Director, Global Medical Affairs Pipeline Hematology is a key member of the Therapeutic Area Leadership Team (TALT), contributing to the cross-functional development of TA strategies and individual global product strategies.Main Responsibilities & AccountabilitiesOversees and directs pipeline TA Medical Directors' activities in developing and...

Job 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...

Parexel 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...

Job 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...

Job 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...

Job 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, 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,...