Drug Regulatory Affairs Specialist

6 months ago


مصر, Egypt Orchidia Pharmaceutical Industries Full time

**وصف الوظيفة**:
**Purpose of the job**:
**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.
- 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



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