Job Description
A Regulatory Affairs Associate must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Associate must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Associate ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Senior Regulatory Affairs Associate assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
We are currently looking for a Regulatory Affairs Associate who will have the following responsibilities:
• Preparation of EU submissions packages (LCM activities - variations, renewals, etc.)
• Change Control assessment
• Provide regulatory support and perform regulatory activities within emerging markets team. This will include meetings between client, local contacts & the distributors, performing day to day regulatory activities relating to labelling, type I, type II variations, NDAs / MAA applications, updating trackers, coordinating activities with distributors/affiliates and client.
• Provide regulatory intelligence support and preparing summaries of the updates in daily/weekly newsletters.
Qualifications
• Good understanding of performing the above regulatory tasks on a regional/global level
• Few years of experience in regulatory Affairs (LCM)
• Good project Management skills
• Proactive approach and good communication skills
• Fluent English and Romanian
Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
