Job Description

We have a compelling opportunity within client-dedicated regulatory team for a Regulatory Affairs professional with extensive global labeling experience and management of cross-functional teams. This is a senior positionopen to candidates from different European locations.

Some of the activities Senior Consultant will be responsible for:

Creating / writing Target Label Profiles

Coordinating CDS updates

Management of cross-functional teams

Creating labelling strategies for marketed products and products in the development phase

Overseeing system updates

Overseeing the development and update of core labelling documents and for tracking implementation at a local and regional level.

Qualifications

Ideal candidate will possess:

BA/BS/University degree required, Life/Health Sciences preferred

5+ years pharmaceutical/biotechnology industry experience

Minimum of 5 years in Regulatory Sciences

Experience in supporting regional/ global labelling strategies

Prior experience managing cross-functional teams

Experience in interpretation of regulations, guidelines, and policy statement

Ability to represent the department in project teams, committees and external meetings

Demonstrate strong organizational skills, including the ability to prioritise workload

Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff

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.