Job Description

This role can be flexibly based in multiple EU locations.

A Regulatory Affairs Consultant 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 Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant 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 Regulatory Affairs Consultant 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 French speaking Regulatory Affairs Consultant who will have the following responsibilities:

MAA and lifecycle maintenance activities in FRANCE

Change Control assessment (application of relevant regulatory guidance to proposed change)

Submissionof Simple (Type I) and complex variations (Type II) to FRANCE in the CP, MRP and NP procedures.

Reviewing promotional materials.

Participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME.

Qualifications

Ideal candidate will possess:

Fluent French and good English

University degree, life science degree preferred

Good understanding of performing the above regulatory tasks on a global level

Several years of MAA and Lifecycle Maintenance experience for FRANCE

Change control assessment experience for EU

Very good project management skills

Proactive approach and excellent communication skills

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.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.