Develop and administer trade compliance training to functional teams to enhance competencies in operational business scenarios. Collaborate with legal, finance, tax, and other functions as needed to make relevant trade compliance determinations. Develop, maintain, and communicate standards to operational teams via master data or other databases to facilitate business flow

The Pennsylvania Director of State Affairs serves as the principal staff for state government affairs and chief lobbyist in Pennsylvania, representing the Alzheimer's Association before Pennsylvania's legislature, governor, relevant state agencies, community stakeholders and coalitions, and on statewide task forces and work groups. This position is responsible for impleme

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

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

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

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

As a combined organization, and is undertaking what is perhaps the central challenge of our times to help drive the transition to net zero carbon economies while ensuring that no working families, businesses, or local communities are left behind. To do that, we are the utility industry's top provider of turn key energy efficiency and grid optimization programs and product

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

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

. Work Schedule and Additional Information Full time employment, 37.5 hours per week Work hours are 8 30 AM to 5 00 PM, Monday Friday, with 60 minute lunch. 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 environment. Travel and overtime as nee

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

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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