As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
- Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
-
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
-
Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
-
Collaboration
Work with industry leaders and subject matter experts.
-
Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
-
Variety
Opportunities to work on multiple accounts – never boring!
-
Management
Strong management with depth of experience working for global health authorities.
Responsibilities
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!
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs