Regulatory Affairs Associate - Labelling
at Parexel
Warszawa, mazowieckie, Poland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Jan, 2025 | Not Specified | 26 Oct, 2024 | 2 year(s) or above | Organization Skills,Critical Thinking,Pil,Trackwise,English,Communication Skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
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.
Responsibilities:
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
REQUIREMENT SUMMARY
Min:2.0Max:7.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
A scientific or technical discipline
Proficient
1
Warszawa, mazowieckie, Poland