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.
Requirements:
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
Advantages:
Bachelor Degree in Lifesciences/Pharmacy preferred
Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience
What does our partner offer?
A career path that will allow you to become a Subject Matter ExperGet trained on various competencies and skills
