- 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.
- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
- A few years of experience in a CRO/Pharma
- Experience in clinical trial submissions to the competent Regulatory Authorities
- Client-focused approach to work
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in English and local language (written and spoken)
- University degree
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Senior Regulatory Affairs Associate - Warszawa, Polska - Parexel
Opis
When our values align, there's no limit to what we can achieve.
We are excited to announce an opportunity for a skilled and experienced Senior Regulatory Affairs Associate to join our dynamic and expanding team at Parexel. This role can be either home or office-based in Croatia, Romania, Poland, Lithuania, Czechia, Serbia and Hungary.
As the Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in C linical Trial Applications (CTA) from various European locations. You will have a chance to work on submissions for Parexel as well as dedicated for clients. In return we will offer you training and knowledge of the organization's basic consulting models and methodologies as well as basic knowledge of what services we provide. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.
Main responsibilities:
Knowledge and experience required for the role:
Parexel is offering a comprehensive benefits package to ensure your success and growth in this role. We provide training and knowledge of our organization's basic consulting models, methodologies, as well as an understanding of the services we offer. Moreover, you will receive support from our senior staff to accomplish more complex tasks successfully.
