We 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 submissions (as

Provides assistance and support to the legal staff by compiling and coordinating the daily flow of documents and information for use in processing legal matters for FedEx Ground (FXG). Essential Functions Prepares, investigates and conducts research for new and ongoing legal matters. Organizes, coordinates, and tracks all legal files and documents, making them available a

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. SUMMARY The Quality Analyst has the primary function to ensure

Regulatory 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 performance of wo

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

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 g

. Work Schedule and Additional Information Full time employment Work hours are 8 30 AM to 5 00 PM, Monday Friday, with a 60 minute lunch. May change based on operational needs. Travel and overtime as needed Shift work No Free Parking! Assigned duties are performed in a controlled office environment. In counties with district offices, employees may be reassigned to differe

Senior 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 ensures the ti

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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 an

. Work Schedule and Additional Information Full time employment, 37.5 hour work week Work hours are 8 30 AM to 5 00 PM, Monday Friday, with 60 minute lunch. May change based on operational needs. The DHS provides excellent benefits, contractual pay increases, paid holidays and leave entitlements, opportunity for advancement and shift selection in addition to a great work

Ensures that all federal regulations are adhered to and maintains up to date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues. Essential Functions Prep

PRIMARY FUNCTION The Regional Compliance Officer (RCO), Thomas Jefferson University, collaborates with Jefferson enterprise compliance team members to establish and implement an effective compliance program designed to identify and manage high risk activities at the regional and enterprise levels. The RCO will monitor and oversee Jeffersonrsquo;s compliance and ethics rel

Under the general direction of the Director of Regulatory Affairs, executes the hospitalrsquo;s regulatory readiness processes to assure compliance with regulations and standards of regulatory and accreditation agencies. Assesses and determines survey readiness and compliance to all accrediting and licensing agencies by identifying areas of noncompliance and works with le

Compliance Specialists are vital members of Jeffersonrsquo;s dynamic and diverse enterprise compliance team. The Compliance Specialist utilizes their excellent communication, strong problem solving and decision making skills to drive key operational activities designed to ensure that members of the Thomas Jefferson University and Jefferson Health community understand and