Regulatory Affairs Associate - Labelling
Warszawa, Poland Job ID R0000028833 Category Regulatory / Consulting Date Posted 11/15/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Parexel, a leading Clinical Research Organization, is seeking a Regulatory Affairs Associate (Labelling) to join our team. As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards. This is a crucial role in ensuring the efficient and accurate implementation of labeling updates across various regions.
The role can be home or office based in various European locations.
Job Responsibilities:
Track the status of ongoing changes to labelling/artwork projects, evaluating regulatory impact when applicable
Document changes and identify countries potentially impacted by the change
Assign Regulatory Affairs Reviewer and Assessment Coordinator(s) to manage changes from initiation to closure
Utilize document management tools to streamline change control processes
Maintain familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
Collaborate with cross-functional teams to ensure smooth coordination between labelling and artwork processes
Demonstrate knowledge of regulatory requirements for labelling updates in different regions, including EU, US, and APAC
Appreciate the relationship between labelling and artwork processes
Skills and Experience required for the role:
University Degree in a Scientific or Technical Discipline
Around 2 years of experience in an industry-related environment
Preferably possess knowledge of SmPC, PIL, and QRD requirements
Exercise good organization skills to effectively manage multiple activities simultaneously
Prior experience using Trackwise is a plus
Client-focused approach to work
Strong interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving abilities
Proficiency in English written and spoken
Additional Information:
You will be working within a dynamic team environment while maintaining autonomy in your area of competence.
There will be opportunities for professional development and growth within the organization.
The successful candidate may occasionally serve as a Project Lead or a Work Stream Lead.
Excellent organizational skills and attention to detail are necessary to excel in this role.
This is a full-time position within our organization.
If you are a highly organized and detail-oriented professional with a strong background in change control management and labelling processes, we encourage you to apply. Join Parexel and contribute to our mission of improving patient lives through clinical research!
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