Job Description

• Manage the review of a new application submission corresponding to company strategy and plan as well as the agency guidelines for submission.
• Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.

• Manage new applications submission corresponding to company plan as well as the authority guidelines for submission.
• Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines.
• Timely implementation of all plans/projects with strict follow up with both internal & external stakeholders for timely achievement of the plans/projects.
• Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling review and approval with respect to internal KPIs.
• Updating internal Sanofi systems regularly and on time following internal KPIs.
• Revision and approval of promotional materials and any updated packaging materials on artwork system.
• Following and complying with all defined internal policies and procedures of working.
• Following strictly all the Authority Regulations, decisions & decrees.
• Carry out all communication and follow up required with local affiliate, region and corporate as appropriate.
• Work in collaboration with internal and external stakeholders to manage issues that might lead to supply impact.
• Familiar with all regulations to support day to day activities.
• Respect quality and compliance aspects.

• Pharmacist, Physician, Veterinarian

• 1-3 years of regulatory affairs experience, preferably in multinational organization

• High level of communication skills and ability to influence other.
• Organization skills and high accuracy in documentation
• High sense of urgency
• Priority setting and management
• Knowledge of new decrees & guidelines
• Multitasker
• Promptness in respond to authorities’ requirements and prompt in deliverables
• Analytical skills
• Ability to alert hierarchy in case of specific situation impacting his/her work environment
• Problem solving skills
• An understanding and appreciation of relevant legal, scientific and manufacturing area

• Stretch to go beyond the level we have operated at up until now .
• Take action instead of waiting to be told what to do .
• Act in the interest of our patients & customers .
• Put the interests of the organization ahead of my own or those of our team .