Drug Regulatory Affairs Specialist

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Responsible for filing necessary applications, all activities relating registration requirements and line extension indications, regulatory approvals,…...

وصف الوظيفة Purpose of the job: Responsible for filing necessary applications, all activities relating registration requirements and line extension indications, regulatory approvals, maintaining of the products registration, and handling all government interactions pertaining to the regulation process for current & future products/lines. Primary Tasks: Responsible for Pharmaceutical products, Dietary supplement, Medical Devices and cosmetics products in the following areas.
Oversee the regulation process for products requiring governmental or international approvals.
Update licensing and collects information on registration instructions and regulations.
Obtain/generate information to be submitted to regulatory authorities and prepares required regulatory dossiers.
Manage the final product submissions and negotiates and communicates effectively with regulatory authorities to obtain timely product approvals & pricing.
Provide direct assistance with the registration of new and existing products in markets supplied by the plant.
Assume regulatory review of labeling content, product and process changes and product documentation.
Manage the distribution of new regulations, standards, policies, and guidelines issued by relevant regulatory authorities that may impact the company.
Archive all related work documents soft and hard copies.
Submit and follow up new registration, Re-registration, variation files for analysis till receiving conformity.
Follow up batches and raw material samples submitted for analysis till receiving conformity.
Maintains a high level of knowledge and skill on current matters concerned with the regulation and approval of medicinal products and devices.
Undertaking and managing regulatory inspections.
Perform any assigned duties related to DRA. المهارات Education, Skills, Experience required:
Bachelor’s degree in pharmaceutical science or science.
From 1 to 3 years of experience in pharmaceutical industry. Extensive knowledge of regulatory applications and procedures.
Experience of Drafting Regulatory Files.
Excellent English, verbal / written communication.
Strong communication skills and networking.
Ability to work well through others.
Excellent computer skills. المؤهلات العلمية

Pharmaceutical science or science

تفاصيل الوظيفة مكان الوظيفة القاهرة, مصر الدور الوظيفي التصنيع الحالة الوظيفية دوام كامل نوع التوظيف موظف عدد الوظائف الشاغرة 1 المرشح المفضل المستوى المهني مبتدئ الخبرة عدد سنوات الخبرة الحد الأدنى: 1 الحد الأقصى: 3 منطقة الإقامة مصر الجنسية مصر الشهادة بكالوريوس

Information :

  • Company : Orchidia Pharmaceutical Industries
  • Position : Drug Regulatory Affairs Specialist
  • Location : Cairo
  • Country : EG

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Drug Regulatory Affairs Specialist job info - Orchidia Pharmaceutical Industries Cairo above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Drug Regulatory Affairs Specialist job info - Orchidia Pharmaceutical Industries Cairo in 11-06-2024 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

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Post Date : 11-06-2024