Regulatory Affairs Specialist
3 weeks ago
About the Role:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with labeling regulations and guidelines.
Key Responsibilities:
- Develop and maintain expertise in key labeling regulations and guidelines, including CCDS and USPI.
- Collaborate with cross-functional teams to ensure accurate and compliant labeling.
- Manage the review and approval of labeling documents in document management systems.
- Coordinate artwork approval processes and manage artwork trackers and systems.
- Ensure compliance with regulatory requirements for labeling and artwork.
Requirements:
- 4+ years of experience in drug development, particularly in labeling, product package coordination, and clinical supplies/packaging.
- Strong understanding of labeling regulations and guidelines.
- Excellent communication and collaboration skills.
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