Boehringer Ingelheim Egypt Jobs | RA/PV Executive

Description:

- To facilitate the internal and external regulatory compliance of Boehringer Ingelheim's (BI's) prescription medicines across the OPU (Operating Unit) – LINEA (Levant, Iraq, Near East Africa) region with the objective of smoothly registering / re-registering BI's products in compliance with the local legislations.
- Support business in OPU through providing accurate product information in a timely fashion to the different functions, whilst adhering to best practice principles and BI's standard operational procedures (SOPs). Providing technical support to the other functions in the OPU.
- Act as a link between the organization and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local legislation.
- Closely monitor and update on regulatory environment by ensuring adequate regulatory intelligence communication to internal stakeholders.
- Act in compliance with the internal procedures and local legislations in the OPU countries.
- Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to support patients and clinical trial subject’s safety and public health in the assigned territory Egypt, Sudan, and Libya.

Responsibilities:

Product and Country 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.

PV Responsibility:
- Fulfills compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.
- Acts as local PV point of contact person (local QPPV) for the national Health Authority as legally required.

Requirements:

- Holder of bachelor of pharmacy degree.
- 2- 4 years Regulatory Affairs experience.
- PV (Pharmacovigilance) experience would be a plus.
- Fluent in English and local language
- Mastering  regulatory IT systems and Microsoft programs

Competencies:

-  Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment.
- Experience in preparing and submitting (New Drug Applications) NDA’s, variations and LC (Label Change) submissions.
- Working with and influencing, opinion leaders, external organizations and facilitating approval of submissions.
- Is driven to continually enhance regulatory expertise, both locally and globally.
- Demonstration of high level of agility, accountability and intrapreneurship
- Excellent communication and negotiation skills

Job Details:

Job/ Career : RA/PV Executive
Primary Location :  Africa, Asia, Australasia-Lebanon
Other Locations :  Africa, Asia, Australasia-Egypt, Africa, Asia, Australasia-Jordan
Organization : EG-Boehringer Ingelheim Egypt
Schedule: Full-time
Function: Regulatory
Posting date: 11/3/2020

Learn More about Boehringer Ingelheim :

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  زورونا من خلال Meetup  بالاسفل )

    

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

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