What are the responsibilities and job description for the Sterile Injectables Labeling Expert position at i-Pharm GxP?
About the Role
We are seeking an experienced Regulatory Labeling Consultant to join our team at i-Pharm GxP. As a key member of our regulatory affairs team, you will be responsible for ensuring that our labeling processes are compliant with relevant regulations and guidelines.
Responsibilities:
- Maintain and update regulatory labeling systems to ensure accuracy and consistency.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Manage label change requests and drive labeling projects from initiation to execution.
- Provide technical expertise and support for labeling issues.
Requirements:
- Bachelor's degree in Regulatory Affairs, Engineering, or a related field.
- 3-5 years of experience in regulatory labeling within the pharmaceutical or medical device industry.
- Strong knowledge of cGMP, FDA, EMA, and USP guidelines.
- Experience with label artwork changes, regulatory submissions, and quality systems.
This is an exciting opportunity to join a dynamic team and contribute to the success of i-Pharm GxP.