- Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required.
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. Skills and Experience required for the role:
- University degree in a science discipline
- Background in clinical trial management
- 1-2 years of Regulatory Affairs experience working with Clinical Trail Applications to local authorities
- Experience with clinical trial submissions on a global scale - preferred
- Eu-CTR working knowledge - preferred
- Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
- IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
- Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
- Customer-oriented and autonomous
- Fluency in English is a must along with the local language.
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HR Associate
2 тижні тому
United Nations Office for Project Services Kyiv, Україна· Job Description · Description · –> · Under the direct supervision of HR Senior Officer and the overall direction of the HR Manager as well as the technical guidance of IPAS HR, the HR Associate is responsible for administering and implementing services, plans, and processes co ...
Senior Regulatory Affairs Associate - Kyiv, Україна - Parexel
Опис
We are looking for an experienced Senior Regulatory Affairs Associate with working knowledge of Clinical Trail Applications (CTA) to join our team in Ukraine. The role can be home or office based in our office in Kyev.
This is a fixed term role for 12 month with a view of extension.
As a Regulatory Affairs Associate you will ensure the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients. You may act as a Project Lead or Work Stream Lead and in this role you will assure the work of the entire team or work stream is delivered on time and that it meets client's quality expectations. You will succeed in this role because will bring your strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
Key Deliverables in the role:
