– Regulatory activities
o Preparations activities for all submissions of the entire Clients NL portfolio (life cycle management and launches), which includes for example:
The preparation and finalizing of the NL labeling.
The preparation and finalization of any local driven documentation according to the law/legislation.
Finalization of the submission package.
Preparation and finalization of the risk minimalization materials (aRMM’s).
Coordination of all activities with Paraxel to ensure submission by submission vendor.
Ensuring on time submission to maintain the submission KPI.
o Implementation of health agency approvals, which includes:
Local database update with the approved NL labeling which is used by the Business and informing the Business of any health authority approval.
Updating/creation of the VPI for promotional activities.
Implementation of Agency approved aRMM’s.
Global database update (like SHARE, RWS-LOL, Veeva Vault, and cross references with SHARE).
– Implementation of health agency approvals
– Industrial implementation
Ensuring Regulatory compliance in our packaging and according to the law/legislation and Sanofi’s policies to ensure completion of the end to end process.
Coordination of minimalization of destruction costs by manufacturing sites.
– Project support for example but not limited to:
CCSI Authoring Project.
Also any local driven business projects like, for example implementation of 2D code on primary label.
– Database management