Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

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

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

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

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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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

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

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

The Associate Regional Compliance Officer (ARCO), Thomas Jefferson University, Jefferson Health Einstein Medical Center Philadelphia will be responsible for supporting the Regional Compliance Officer (RCO) in the oversight of all activities, functions, and initiatives related to the development, implementation, oversight, and maintenance of the Corporate Compliance and Et

PRIMARY FUNCTION The Associate Regional Compliance Officer (ARCO), Thomas Jefferson University ndash; Center City, will be responsible for assisting the Regional Compliance Officer (RCO) in the oversight of all activities, functions, and initiatives related to the development, implementation, oversight, and maintenance of the Corporate Compliance and Ethics Program, which

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

Rutgers, The State University of New Jersey is seeking a Principal Auditor for Office of Audit and Advisory Services. Reporting to the Audit and Advisory Services' ( AAS ) Manager of Audit and Advisory Services Financial, Operational, and Investigations, the Principal Auditor position exists to provide professional, independent, objective assurance and consulting services