Senior Regulatory Affairs Associate (CTA)

We are looking for aSenior Regulatory Affairs Associate to join our growing team in Romania.This role can be either home or office based in Bucharest.

As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail 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.

Knowledge and Experience required for the role:

• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline

• Few years of experience in an industry-related environment

• 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 language