- 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
- 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