Budapest

• To assist the Publishing & Regulatory Data Entry Manager in providing Global Submission view and strategy Worldwide, in line with Regulatory Strategic Planning.
• To ensure that metadata submitted to the Health Authorities (HA) and coming from HA are accurate and that Ipsen Regulatory tracking system is aligned
• To assess Submission strategy impact on Regulatory Tracking System and ensure that Regulatory Tracking System is appropriately maintained.
• To oversight Service provider(s) for the Centralized Data Entry and HA document upload activities
• Promotes/Communicates on Regulatory Data process/timeline with RA community, and contributes to the planning of the regulatory submission.
• Ensures that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stake-holders.
• Maintains a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory Operations teams in particular with regards to tracking.

• Strong analytical and problem-solving capability with attention to detail
• Strong written and oral communication skills
• Must exhibit excellent interpersonal, collaborative and team spirit mindset, good communication and follow-up skills
• Good judgment and decision-making skills
• Good negotiating and influencing skills
• Excellent planning, coordination and Project Management skills
• Willingness to work in a fast-paced environment with stringent timelines
• Experience in continuous improvement projects and quality management

• Bachelor Degree in Lifesciences/Pharmacy preferred
• Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience

• A career path that will allow you to become a Subject Matter Expert
• A great diversity of cultures
• Language courses and training
• On-site relax & gym rooms
• Volunteering, sport and employee events
• Get trained on various competencies and skills