الصفحة الرئيسية مصر Regulatory Affairs Specialist (One Year Contract)
الصفحة الرئيسية مصر Regulatory Affairs Specialist (One Year Contract)
Regulatory Affairs Specialist (One Year Contract)
دوام كامل
في sanofi
في
Egypt
نُشرت يوم April 25, 2024
تفاصيل الوظيفة
Job Description
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.
- 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 .
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Affairs Specialist (One Year Contract)', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => '<h2> Job Description </h2><p><p><b> JOB PURPOSE </b><b> : </b></p><ul><li> Manage the review of a new application submission corresponding to company strategy and plan as well as the agency guidelines for submission. </li><li> Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines. </li></ul><p><b> KEY RESPONSIBILITIES AND DUTIES: </b></p><ul><li> Manage new applications submission corresponding to company plan as well as the authority guidelines for submission. </li><li> Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines. </li><li> Timely implementation of all plans/projects with strict follow up with both internal & external stakeholders for timely achievement of the plans/projects. </li><li> Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling review and approval with respect to internal KPIs. </li><li> Updating internal Sanofi systems regularly and on time following internal KPIs. </li><li> Revision and approval of promotional materials and any updated packaging materials on artwork system. </li><li> Following and complying with all defined internal policies and procedures of working. </li><li> Following strictly all the Authority Regulations, decisions & decrees. </li><li> Carry out all communication and follow up required with local affiliate, region and corporate as appropriate. </li><li> Work in collaboration with internal and external stakeholders to manage issues that might lead to supply impact. </li><li> Familiar with all regulations to support day to day activities. </li><li> Respect quality and compliance aspects. </li></ul><p><b> JOB-HOLDER’s ENTRY REQUIREMENTS </b><i> : </i></p><p> Education: </p><ul><li> Pharmacist, Physician, Veterinarian </li></ul><p> Related Experience: </p><ul><li>1-3 years of regulatory affairs experience, preferably in multinational organization </li></ul><p> Special Knowledge/Skills: </p><ul><li> High level of communication skills and ability to influence other. </li><li> Organization skills and high accuracy in documentation </li><li> High sense of urgency </li><li> Priority setting and management </li><li> Knowledge of new decrees & guidelines </li><li> Multitasker </li><li> Promptness in respond to authorities’ requirements and prompt in deliverables </li><li> Analytical skills </li><li> Ability to alert hierarchy in case of specific situation impacting his/her work environment </li><li> Problem solving skills </li><li> An understanding and appreciation of relevant legal, scientific and manufacturing area </li></ul><p> PTW Behaviors: </p><ul><li> Stretch to go beyond the level we have operated at up until now . </li><li> Take action instead of waiting to be told what to do . </li><li> Act in the interest of our patients & customers . </li><li> Put the interests of the organization ahead of my own or those of our team . </li></ul><p> At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. 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specific substances and materials.<br> Because the possibility of being injured while working in a hazardous workplace is constantly there, it is critical to instruct your employees on how to keep themselves safe from these hazardous substances.<br> <br> In our COSHH for Construction Course, the learner will gain adequate knowledge of the maintenance methods of hazardous substances, assess COSHH risk assessments, the duties imposed on employers and employees, current relevant legislation, precise control measures, and safe practices.<br> <br> <strong>Special Offer</strong> <ul> <li>Learner will get Free Certificate</li> <li>No Extra fees</li> <li>Lifetime Course Access</li> </ul> <strong>Why Choose the COSHH for Construction course?</strong> <ul> <li>Developed by Qualified Professionals With Updated Materials</li> <li>24/7 Learning Support and Assistance</li> <li>Course completion free PDF certificate</li> <li>High-quality E-learning Study Materials</li> <li>No Hidden Fees or Exam 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الشركة المعلنة عن الوظيفة
Sanofi
Sanofi multinational pharmaciieutical company in Egypt
Ibd3a Academy in Egypt
Brooklen Academy
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خذ دورة عبر الإنترنت على الصحة والسلامة ابتداءً من الآن.
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