Regulatory Affairs Specialist at Sanofi
Cairo
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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 a new application submission corresponding to company 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
Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
Maintain the products labelling up to date, implementing global and local labelling decisions , through labelling, review and approval
Updating the internal Sanofi Systems regularly
Carrying the planned LCM activities and reflecting the approvals on the internal systems
Revision and approval of promotional Materials any updated packaging material on VISTA
Preparation, submission and follow up of pricing files internally and externally
Assure compliance with IA files
Following and complying with all the defined internal policies and procedures of working
Following strictly all the Authority Regulations, decisions & decrees
Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
Carrying the planned Activities and reflecting the approvals on the internal system
Revision and approval of Promotional Materials & any updated packaging material.
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education:
Medical Background
Related Experience:
Up to 3 years of relevant experience, preferably in Pharma 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
Promptness in respond to authorities requirements and prompt in deliverables
Analytical skills
Problem solving skills
An understanding and appreciation of relevant legal, scientific and manufacturing area
PTW Behaviors:
Stretch to go beyond
Take action instead of waiting to be told what to do
Act in the interest of our patients & customers
Put the interest of Organization ahead