Regulatory Site Specialist At Sanofi Egypt
JOB PURPOSE:
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.
KEY RESPONSIBILITIES AND DUTIES:
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.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education:
Pharmacist, Physician, Veterinarian
Related Experience:
1-3 years of regulatory affairs experience, preferably in multinational organization
Special Knowledge/Skills:
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