Job Description
We are recruiting for A Senior Regulatory Affairs Associate in Bucharest, Romania. We are looking for experienced candidates who have strong technical skills and ensure the timely performance of work within a project scope to meet quality expectations of the internal regulatory department and the sponsor. It is essential to be self motivating and a leader as 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 PAREXEL Consulting’s quality expectations.
We are currently looking for a Senior Regulatory Affairs Associate who will have the following responsibilities:
- Support Global Labelling Strategic Plan, Labelling Lead activities,
- Harmonizing Local Labels
Core labelling activities: (creation/update of – CCDS, USPI, SmPC, PIL)
- Red line documents
- Authoring of labelling documentation, artwork, SPL
- Development of Regulatory Intelligence Database
Qualifications
• Good understanding of performing the above regulatory tasks on a global level
• Minimum of 3 years of Variation/ Lifecycle Maintenance experience alongside a science related university degree
• Relevant Labelling Regulatory expertise
• Good project Management skills
• Proactive approach and excellent 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.
