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Regulatory Affairs Professional
hace 4 meses
When our values align, there's no limit to what we can achieve.
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.
