Senior Regulatory Affairs Associate (MAA & CMC)

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 DatabaseQualifications• 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