محتويات الصفحة
Job purpose
:
To manage & monitor the Consumer Health Regulatory activity (renewal, variation, new launches,pricing, promotion materials).
Responsibilities
:
1- Interface with various project/product teams.
2- Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
3- Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
4- Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
5- Manage the maintenance of a portfolio of products.
6- Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
7- Provide support and communicating information on products to other functions (submissions, approvals, etc.).
8- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
9- In liaison with his/her manager, can be involved in activities such as shortages, DHPC (in collaboration with Pharmacovigilance department), B/R reevaluation, etc.
10- Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
11- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
12- Plan for preparation / review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
13- Plan for preparation / review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.
14- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
15- Maintain the products labeling up to date, implementing global and local labeling decisions , through labeling preparation, review and approval
16- Updating the internal Sanofi Systems regularly
17- Carrying the planned LCM activities and reflecting the approvals on the internal systems
18- Preparation, submission and follow up of pricing files internally and externally
Assure compliance with IA files
19- Following and complying with all the defined internal policies and procedures of working
20- Following strictly all the Authority Regulations, decisions & decrees
21- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
22- Ensure the management of the artworks Use of the Vista & VistaVac tools for the management of the artworks
- Download the dossiers to Vista & VistaVac tools
- Use veeva vault & RT
23- Ensure update the databases (Veeva Vault)
- Update the regulatory events in databases (Veeva Vault)
- Monitor the regulatory events in databases (Veeva Vault)
24- Ensure the administrative documents related with PoA, CPP, GMP
- Prepare the administrative documents related with PoA, CPP,GMP by using mail, legalization, translation requests, posting and archiving in the countries concerned and exportation if applicable.
25- Ensure all documents are translated in compliant with Health Authority requirements
- Know the Health Authority requirements
- Ensure all documents are translated in compliant with Health Authority requirements
26- Ensure regulatory compliance with products and country requirements
- Ensure regulatory compliance with products overall strategies
- Ensure regulatory compliance with Health authorities country requirements evolution
2- Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
3- Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
4- Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
5- Manage the maintenance of a portfolio of products.
6- Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
7- Provide support and communicating information on products to other functions (submissions, approvals, etc.).
8- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
9- In liaison with his/her manager, can be involved in activities such as shortages, DHPC (in collaboration with Pharmacovigilance department), B/R reevaluation, etc.
10- Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
11- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
12- Plan for preparation / review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
13- Plan for preparation / review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.
14- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
15- Maintain the products labeling up to date, implementing global and local labeling decisions , through labeling preparation, review and approval
16- Updating the internal Sanofi Systems regularly
17- Carrying the planned LCM activities and reflecting the approvals on the internal systems
18- Preparation, submission and follow up of pricing files internally and externally
Assure compliance with IA files
19- Following and complying with all the defined internal policies and procedures of working
20- Following strictly all the Authority Regulations, decisions & decrees
21- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
22- Ensure the management of the artworks Use of the Vista & VistaVac tools for the management of the artworks
- Download the dossiers to Vista & VistaVac tools
- Use veeva vault & RT
23- Ensure update the databases (Veeva Vault)
- Update the regulatory events in databases (Veeva Vault)
- Monitor the regulatory events in databases (Veeva Vault)
24- Ensure the administrative documents related with PoA, CPP, GMP
- Prepare the administrative documents related with PoA, CPP,GMP by using mail, legalization, translation requests, posting and archiving in the countries concerned and exportation if applicable.
25- Ensure all documents are translated in compliant with Health Authority requirements
- Know the Health Authority requirements
- Ensure all documents are translated in compliant with Health Authority requirements
26- Ensure regulatory compliance with products and country requirements
- Ensure regulatory compliance with products overall strategies
- Ensure regulatory compliance with Health authorities country requirements evolution
Others:
- 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
Key working relationships internal
:
Cross Functional Collaboration with:
- COE Cluster Heads
- Regional/Affiliate RA Heads
- Regional/Affiliate Managers
- Regional/Affiliate Associates
- CMC&Medical devices department
- Labeling department
- RSOs
- Regulatory Excellence teams
Occasional Contact with:
- Supply chain
- Business units
EXTERNAL
Would be expected to be involved with:
- Vendors/service provider
- Manufacturer associations
- COE Cluster Heads
- Regional/Affiliate RA Heads
- Regional/Affiliate Managers
- Regional/Affiliate Associates
- CMC&Medical devices department
- Labeling department
- RSOs
- Regulatory Excellence teams
Occasional Contact with:
- Supply chain
- Business units
EXTERNAL
Would be expected to be involved with:
- Vendors/service provider
- Manufacturer associations
Qualifications
:
- Education Level: bachelor's pharmacy, science or vet.
- Experience: Minimum of 2-4 years experiences in Regulatory Affairs field (Consumer Health experience will be an asset) .
- Skills :
1- Project management experience in the pharmaceutical industry or in a regulatory environment.
2- Knowledge in regulatory requirements and Good Manufacturing practices of the cluster
3- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
4- Ability to work with multi-functional and multicultural teams
5- Ability to act as a Business Partner and customer oriented
6- Ability to communicate effectively and efficiently with other functional departments in the business
7- Good relationship ability
8- Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.
9- Ability to foresee and respond to potential problems and opportunities
10- Language requirements: Fluent in English
- Experience: Minimum of 2-4 years experiences in Regulatory Affairs field (Consumer Health experience will be an asset) .
- Skills :
1- Project management experience in the pharmaceutical industry or in a regulatory environment.
2- Knowledge in regulatory requirements and Good Manufacturing practices of the cluster
3- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
4- Ability to work with multi-functional and multicultural teams
5- Ability to act as a Business Partner and customer oriented
6- Ability to communicate effectively and efficiently with other functional departments in the business
7- Good relationship ability
8- Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.
9- Ability to foresee and respond to potential problems and opportunities
10- Language requirements: Fluent in English
Competency Requirements
:
- Act for Change
- Strive for results
- Cooperate Transversally
- Commit to Customer
Job Details:
Job/ Career : CHC Regulatory specialist
Location: Cairo, Egypt
Contract Type: Full time
Company: Sanofi
Posting-Date: 22-7-2020
Expire Date: not known
Expire Date: not known
المختصر المفيد
الوظيفة ( أخصائي تنظيم صحة المجتمع(العملاء) بشركة سانوفى ) ومتطلبات الوظيفة كالتالى:
1) المؤهل العلمي: صيدلة - علوم - طب بيطرى
2) الخبرة ذات الصلة : خبرة لا تقل عن 2-4 سنوات في مجال الشئون التنظيمية (ستكون خبرة صحة المستهلك أحد الأصول).
المهارات:
1) خبرة في إدارة المشاريع في صناعة الأدوية أو في بيئة تنظيمية
2) المعرفة بالمتطلبات التنظيمية وممارسات التصنيع الجيدة
3) القدرة على إنتاج اتصالات تنظيمية أو علمية مكتوبة وشفوية بوضوح ودقة وصدق
4) القدرة على العمل مع فرق متعددة الوظائف ومتعددة الثقافات
5) القدرة على العمل كشريك تجاري وموجه للعملاء
6) القدرة على التواصل بكفاءة وفعالية مع الأقسام الوظيفية الأخرى في العمل
7) القدرة على انشاء علاقات جيدة
8) مهارات تنظيمية جيدة والقدرة على إدارة عبء عمل كبير تحت الضغط والتعامل مع المواعيد النهائية الضيقة.
9) القدرة على التنبؤ والاستجابة للمشكلات والفرص المحتملة
متطلبات اللغة : يجيد اللغة الإنجليزية
2) الخبرة ذات الصلة : خبرة لا تقل عن 2-4 سنوات في مجال الشئون التنظيمية (ستكون خبرة صحة المستهلك أحد الأصول).
المهارات:
1) خبرة في إدارة المشاريع في صناعة الأدوية أو في بيئة تنظيمية
2) المعرفة بالمتطلبات التنظيمية وممارسات التصنيع الجيدة
3) القدرة على إنتاج اتصالات تنظيمية أو علمية مكتوبة وشفوية بوضوح ودقة وصدق
4) القدرة على العمل مع فرق متعددة الوظائف ومتعددة الثقافات
5) القدرة على العمل كشريك تجاري وموجه للعملاء
6) القدرة على التواصل بكفاءة وفعالية مع الأقسام الوظيفية الأخرى في العمل
7) القدرة على انشاء علاقات جيدة
8) مهارات تنظيمية جيدة والقدرة على إدارة عبء عمل كبير تحت الضغط والتعامل مع المواعيد النهائية الضيقة.
9) القدرة على التنبؤ والاستجابة للمشكلات والفرص المحتملة
متطلبات اللغة : يجيد اللغة الإنجليزية
- للمزيد من المعلومات عن الوظيفة >>> نص الإعلان هو الإنجليزى فوق وفيه تفاصيل أكثر
- للتسجيل فى الوظيفة >>> اضغط على زر( التسجيل الآن) بالأسفل
- لزيارة إعلان الوظيفة على الموقع الرسمى للشركة >>> اضغط على زر( التسجيل الآن) بالأسفل
- لمعرفة المزيد من المعلومات عن الشركة >>> اضغط على زر (صفحة المعلومات) بالأسفل
كارت ببعض المعلومات عن شركة سانوفى:
سانوفي وهي شركة فرنسية ذات مناشئ عالمية مختلفة مقرها في باريس، فرنسا . تعمل سانوفي في البحث والتطوير، صناعة وتسويق الأدوية ..........( لمعرفة المزيد عن الشركة زورنا من خلال صفحة المعلومات بالاسفل )
المقر الرئيسى : باريس , فرنسا
العنوان فى مصر : الأميرية الشمالية، الزيتون، محافظة القاهرة
العنوان فى السعودية: نجود سنتر ، جدة ، المملكة العربية السعودية
العنوان فى مصر : الأميرية الشمالية، الزيتون، محافظة القاهرة
العنوان فى السعودية: نجود سنتر ، جدة ، المملكة العربية السعودية
مواقع التواصل الاجتماعى الخاصة بهم :
لزيارة الموقع الرسمى للشركة - اضغط على :
للتسجيل فى الوظيفة , اضغط على :
