What are the responsibilities and job description for the Regulatory Compliance Specialist position at i-Pharm GxP?
Job Description
As a highly skilled Regulatory Labeling Consultant, you will play a critical role in ensuring regulatory compliance and improving labeling processes for sterile injectables and medical devices at i-Pharm GxP.
Key Responsibilities:
- Develop and maintain regulatory labeling systems to ensure compliance with FDA, EMA, and related global standards.
- Manage label change requests (LCR) to support product lifecycle updates and regulatory submissions.
- Collaborate with cross-functional teams, including regulatory, quality, and manufacturing, to ensure label updates meet both regulatory and internal requirements.
- Identify and implement process improvements to enhance efficiency, compliance, and risk mitigation within labeling workflows.
- Drive labeling projects from initiation to execution, ensuring timelines align with regulatory and product launch requirements.
- Provide technical expertise and support for labeling issues, ensuring all label specifications adhere to global regulatory standards.
Qualifications:
- 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, with specific expertise in sterile injectables.
- Strong knowledge of cGMP, FDA, EMA, and USP guidelines.
- Experience with label artwork changes, regulatory submissions, and quality systems.
- Proven ability to manage multiple projects simultaneously and collaborate with cross-functional teams.
