القائمة الرئيسية

الصفحات

  Senior Regulatory Specialist At Sanofi

Senior Regulatory Specialist At Sanofi


JOB PURPOSE:                       

The Sr. Regulatory Specialist will be responsible for ;


Lead and Plan the  review of a new application submission corresponding to company  strategy and plan as well as the agency guidelines for submission.

Lead and plan for  the  review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.

Managing and leading all the transversal activities, dashboard, projects across all GBUs (at country level).  


KEY RESPONSIBILITIES AND DUTIES:

According to the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products,

Interface with various project/product teams.

Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.

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 (approvals, ...).

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.

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

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.

Revision and approval of Promotional Materials &  any updated packaging material.

Managing and leading all the transversal activities, dashboard, projects across all GBUs (at country level).  

Consolidate data needed from different GBUs and deliver it to global team on time

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 requirements:

Education:

Pharmacist, Physician, Veterinarian or preferably Life Sciences Master Degree

Related Experience:

Min 4 years of  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

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

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