Regulatory Affairs Associate CTA (fixed term contract)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.