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This position works within a team of Regulatory Affairs professionals to ensure regulatory compliance of GEHC pharmaceutical products, at national level.
- Ensures regulatory compliance and optimization of the quality processes relevant to submissions, and post submission questions for GEHC medicinal products in Italy
- Investigates regulatory history of similar products to assess approval implications
- Conducts research on submission requirements and options
- Assists in monitoring and reporting project timelines
- Responds to RA information requests
- Communicates license approvals when received
- Reviews promotion material ensuring it is consistent with approved claims for regulated products
- Assists in the preparation of submission packages for local agency in compliance with specific local requirements
- Supports the local pharmacovigilance responsible pharmacovigilance
- Supports regulatory inspections as required
- Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager
- University degree in scientific areas
- Significant experience in regulatory affairs
- Ability to communicate effectively in English (both written and oral)
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet,
- presentation, and database applications.
- Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality
- Management System, Quality Management Policy, Quality Goals, and applicable laws and
- regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- EU work permit
- Strong experience in a regulated industry is preferred
- Ability to work independently in fast-paced environment with little supervision
- Ability to adapt to constant change and influence positive change effectively
- Attention to Detail and Results-Oriented
- Ability to understand technical documentation and execute associated procedure
Locations: Italy; Milan