Senior Regulatory Affairs Consultant

We are recruiting for a Senior Regulatory Affairs Consultant in Bucharest, Romania. The suitable candidate must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides.

Key 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

- Ensures the timely performance of work within a project scope to the quality expectations of Parexel Consulting and the client.

- Assure the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.

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

• Minimum of 7 years of Variation/ Lifecycle Maintenance experience combined with a science related degree

• Relevant Labelling Regulatory expertise

• Good project Management skills

• Proactive approach and excellent communication skills

• Fluent English and Romanian