Senior Regulatory Affairs Specialist – Medical Devices

Senior Regulatory Affairs Specialist – Medical Devices

الوصف الوظيفي

Senior Regulatory Affairs Specia…
– Nasr City, Cairo
Senior Regulatory Affairs Specialist – Medical Devices
– Nasr City, Cairo
Posted 7 hours ago 1 open position
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Experience Needed: 2 to 5 years Education Level: Bachelor's Degree
Job Details
Career Level: Experienced (Non-Manager) Gender: Female Salary: 8000 to 10000 EGP Per Month, Bonus and rewarding programs are performance driven subject to set business objectives and their attainment Job Categories:
Skills And Tools:
Job Description
Job Purpose:
The Regulatory Affairs Specialist acts as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation and versus plan timelines
We Are Hiring Senior Regulatory Affairs Specialist
Job Description :

Plan the review of a new application submission corresponding to company plan as well as the agency guidelines for submission.

Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines

Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.

Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling, review and approval

Updating the internal DKT DMFs regularly

Revision and approval of promotional Materials any updated packaging material on VISTA

Preparation, submission and follow up of pricing files internally and externally

Following and complying with all the defined internal policies and procedures of working

Following and complying strictly with Toll

Companies with all assigned pharmaceutical Products.

Following up strictly shipment & all logistics of assigned products with our agent

Following strictly all the Authority Regulations, decisions & degrees

Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.

Carrying the planned Activities and reflecting the approvals on the internal system

Revision and approval of Promotional Materials & any updated packaging material

Perform other duties as assigned.

Respect of company’s values, code of ethics and social charter.

Respect of personal data protection charter
Job Requirements
Job Requirement :

Bachelor's Degree in Pharmaceutical Sciences/ Vet./ Science.

Females Only

Experience in Medical Devices is a must

2-5 years of experience in a similar position

V. Good command of English language written & spoken

Proficiency in MS Office: Word, Excel, PowerPoint

الوصف الوظيفي

تفاصيل الوظيفة

منطقة الوظيفة

القاهرة, مصر

قطاع الشركة

مكاتب المحاماة

طبيعة عمل الشركة

غير محدد

نوع التوظيف

غير محدد

الراتب الشهري

غير محدد

عدد الوظائف الشاغرة

غير محدد

تفاصيل الوظيفة