Regulatory Affairs Associate CTA (fixed term contract)
Primary Location: Poland, Remote 求人ID R0000044785 Category Regulatory / Consulting
About this Role
We are looking for a Regulatory Affairs Associate to join our Clinical Trial Application team in Poland. The role can be home or office based and we offer a temporary contract (17 months).
As a Regulatory Affairs Associate will have a chance to work on submissions for Parexel as well as dedicated for clients. You will work on Clinical Trial Applications (CTA) in various European locations. 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.
Main responsibilities:
Supports 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.
Ensures project team understands contract scope and identifies new business opportunities through change in scope
Maintains client satisfaction through professional service delivery
Delivers consulting services within area of expertise under guidance of Project Lead or Technical SME
Produces quality work meeting project lead and client expectations
Knowledge and experience required for the role:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
Initial years of experience working in a CRO/Pharma
Experience in Regulatory Affairs
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)
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.
Salary benchmarking for the role: 105,624.00 - 158,436.00 PLN gross per annum
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives. Our Talent Acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.
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