Regulatory Affairs specialist CHC- Egypt At Sanofi
CHC portfolio (Ex-BI/ CHC portfolio)
Secure the submission and approval of variations for products portfolio
Secure the submission and approval of renewals for products portfolio
Secure the submission and approval of New launches for products
KEY RESPONSIBILITIES AND DUTIES:
Interface with various project/product teams.
Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
Manage the maintenance of a portfolio of products.
Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
Provide support and communicating information on products to other functions (submissions, approvals, etc.).
Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
In liaison with his/her manager, can be involved in activities such as shortages, DHPC (in collaboration with Pharmacovigilance department), B/R reevaluation, etc.
Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
Plan for preparation / review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
Plan for preparation / 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 labeling up to date, implementing global and local labeling decisions , through labeling preparation, 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.
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:
Bachelor of Pharmaceutical Sciences
Total Experience of minimum 2-4 years in any regulatory activities
Computer Skills, Negotiation & Communication Skills.
Good planning and organization skills
Good Command of English Language
Play to win behavior:
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 and customers.
Put the interests of the organization ahead of my own or those of our team.