CDD Pharmacien Affaires Réglementaires Junior H/F

Description de l'offre

Supervision

Under supervision of Therapeutic Area (TA) experts and hierarchical link to a TA Expert manager

Overall responsibilities:

· In accordance with internal SOPs, local and EU legislation, to perform regulatory, registration and compliance activities for their specific product portfolio and for some other products in support of the RA Experts :

Registration
· Preparation and timely submission of regulatory CMC and CCDS MAA variations
· Follow up of Authorities' assessment
· Implementation of Authorities' decision
· As required translations of MA annexes/ product information

Compliance
· Complete check lists related to registration activities
· Update regulatory databases
· Update SOPs in relation with their activity
· Maintain the product label and packaging in line with the current approved registered authorization according to relevant local and EU legislation
· Review of packaging components artworks
· Management of at risk stock-out situations

Responses to r equests received from Customers/Health Care Professionals via the Call Center

Regulatory Intelligence
· Maintain constant awareness of regulatory regulation and requirements
· Participate to the Regulatory Intelligence activity as required

· To participate to internal Workstreams/Working Groups, CVTs , Proper Use Monitoring Committee as required and address any regulatory actions

Key accountabilities:

· To perform all required operational product tasks, following the plan and updates from EMEA and TA Experts
· To update regulatory databases they are responsible for

Profil recherché

Skills and capabilities:

·  In depth knowledge of regulations/legislation
·  Strong in data gathering & interpretation
·  Analytical, detail driven
·  Oral and written communication skills
·  Constructive team player
·  Ability to work in matrix organization
·  Very good knowledge of English, verbal and written
·  Multitasking, accurate and conscientious
·  Knowledge of regulatory IT systems (document management, planning, databases….)

Internal and external contacts:

External
·  ANSM : ensure interaction with ANSM as needed on product specific topics

Internal
·  GRA – EMEA RA
·  All departments interacting with RA : medical affairs, PV, supply chain, commercial, market access, marketing, BI….

Experience:

0-3 years' experience, beginner to RA. Previous experience in RA role as Associate, Professional or similar role is of advantage