Regulatory Affairs Professional - Labelling (EU/UK)

Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe. As part of our team, you will have the opportunity to work within a collaborative environment and deliver services within your technical expertise. Join us and make a difference in clinical research!

Main Role Responsibilities:

• Demonstrate the ability to prioritize work and define steps needed to achieve project outcomes.

• Liaise closely with more senior colleagues to discuss issues and resolve conflicts.

• Provide suggestions for improving project efficiencies and results to the project technical lead.

• Seek out information from previous projects, other client work, or colleagues to complete assigned project activities.

• Produce quality work that meets the expectations of the project Team Lead and the client.

• Serve as a Regulatory Lead for small scale projects or work streams.

• Ensure accurate project reporting is in place as the main client contact.

• Ensure project team compliance and adherence to project scope and objectives.

• Identify new opportunities through Change In Scope or add-on businesses from existing work.

• Ensure timely project close-out activities are completed.

• Follow and implement the organization's consulting models and methodologies.

• Provide technical and/or business consulting services within your personal area of expertise.

Requirements:

• Previous experience working in industry in support of Global Labeling, Regulatory (Clinical/Safety), or Medical Writing for labeling updates.

• Understanding of the Regulatory processes required to update labeling of a product.

• Familiarity with the Company Core Datasheet (CCDS), and its implementation into labeling and artworks.

• Understanding of Safety Signal Management and the impact of confirmed safety signals on labeling.

• Understanding of Periodic Safety Update Reports (PSUR) and potential impact on labeling.

• Knowledge of the relationship between labeling and artwork processes.

• Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labeling variation.

• Knowledge of Regulatory requirements for labeling updates in different regions (EU, US, and APAC).

• Understanding of EU readability and PIL (Patient Information Leaflet) testing.

Skills and Qualifications:

• University degree in a scientific field

• Strong organizational and time management skills.

• Excellent communication and oral skills, with the ability to work efficiently as part of a team.

• Strong interpersonal skills.

• Proactive and efficient work ethic.