Boehringer Ingelheim Egypt Jobs | Regulatory Affairs Executive

محتويات الصفحة

1. Description
2. Responsibilties
3. Requirements
4. Competencies
5. Job Details
6. المختصر المفيد
7. كارت ببعض المعلومات عن شركة بورنجير إنجلهايم
8. رابط التسجيل

Description:

- To execute the Regulatory Affairs local activities according to regional Regulatory Affairs strategies and local business priorities within the defined time lines.

- Maintain product registrations and Regulatory Affairs databases; ensuring business continuity in compliance with internal and external regulations and requirements.

- Provide regular regulatory intelligence on changes in regulatory environment, competitor activity to enable the business to realize any risks or opportunities arising in the RA environment.

- Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics.

- Have a strong interaction and partnership with the assigned authorities across in the operating unit; maintain efficient relationships with related Regulatory service Providers (local agents and vendors). 

- Carry out agreed actions for the assigned local projects.

Responsibilties:

Product Responsibility 

- Product registration.

- Acts as a product 'passport' enabling function by obtaining local marketing authorizations and appropriate legal approvals.

- Maintains licenses for products and seeks approval for product re-registration on permit / license expiry in accordance with the local legislations.

Product Information

- Provides packaging component updates. Evaluates the preparation of the product artworks for data accuracy as per the latest product information.

- Maintains product information accuracy and appropriateness with respect to drug contents, drug safety / and pharmacovigilance and drug usage information.

- Maintains effective communication with Marketing and Medical Affairs Departments to ensure that the product information integrity and communicates changes in product content where necessary.

Regulatory compliance

- Maintains regulatory compliance of products with internal and external bodies at the international, regional and local levels. Adapts local requirements and procedures to corporate standards

- Reviews product / legislative updates received from BI Corporate or local health authorities and ensure that products are compliant.

- Maintains an in-house repository of relevant laws and local authority guidelines. Archives regulatory updates issued by health authorities across the OPU region. Communicates updates and assists with special requests from Corporate regarding local / regional regulations.

-  Ensures company compliance to regulatory obligations and maintains licenses/authorizations for existing products

- Communicates periodically to the agencies on PSUR and safety data issued by BI Corporate and forwards to the QPPV in the OPU.

Country responsibility

- Support the local Regulatory Affairs team with their products of responsibility to feed in the country requirements for their plan, to respond to these needs within the set timelines identified by the team member.

- Prepare and communicate a regulatory intelligence report on any new issued regulation / guideline / circular and to brief the regulatory colleagues.

- Support the local Regulatory Affairs team with the local submission and follow up with the local Health Authority for the country of concern.

Requirements:

- Pharmaceutical or medical degree, Life-Science degree is acceptable

- Pharma background with regulatory focus for at least 2-4 years’ experience

- Experience preferably within multi-national and/Or direct interactions with Regulatory Authorities is an asset.

Competencies:

- High level of learning agility, 

- Dealing and managing ambiguous situations, 

- Team player approach, 

- Detail orientation, 

- Time management

Job Details:

Internship :  Regulatory Affairs Executive
Primary Location : Africa, Asia, Australasia-Egypt
Organization : Boehringer Ingelheim
Schedule : Full-time
Job Posting date: 17-9-2020
Job Closing date: not known

المختصر المفيد

الوظيفة (مسئول الشؤون التنظيمية فى شركة بورنجير إنجلهايم ) - والمتطلبات كالتالى:
1) حاصل على درجة جامعية فى الصيدلة - الطب - علم الحياة
2) خلفية عن الفارما 
3) خبرة سابقة لا تقل عن ٢-٤ في الشؤون التنظيمية 

- 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 بورنجير إنجلهايم :

C.H. Boehringer Sohn AG & Ko. K هى الشركة الأم لمجموعة  بورنجير إنجلهايم والتي تأسست في عام 1885 من قبل ألبرت بورنجير  ...........( لمعرفة المزيد عن   زوروا صفحة المعلومات بالأسفل )

المقر الرئيسى : إنغلهايم ، ألمانيا
العنوان  فى مصر : شارع الملتقى العربى، قسم النزهة، محافظة القاهرة‬
العنوان  فى السعودية : طريق الإمام سعود بن عبدالعزيز بن محمد، الملك فهد، الرياض ، السعودية
العنوان فى الإمارات: ذا إندكس ، الطابق ال 13 و ال 15 ، مركز دبي المالي العالمي ، دبي ، الإمارات

مواقع التواصل الاجتماعى الخاصة بهم :

لمعرفة المزيد من المعلومات عن شركة بورنجير إنجلهايم , يمكنك زيارة صفحة المعلومات التالية:

لزيارة الموقع الرسمى للبنك - اضغط على :

للتسجيل فى الوظيفة , اضغط على :