What are the responsibilities and job description for the GxP Regulatory Affairs Manager position at i-Pharm GxP?
Regulatory Labeling Consultant Job Description
i-Pharm GxP is seeking an experienced Regulatory Labeling Consultant to join our team. The successful candidate will be responsible for maintaining and updating our regulatory labeling systems, collaborating with cross-functional teams, and managing label change requests.
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.
The ideal candidate will have excellent communication and project management skills, as well as the ability to work collaboratively in a team environment.
