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Regulatory Affairs Specialist

Ameco Medical Industries

2 - 4 years Egypt - Egypt

Bachelor of Pharmacy(Pharmacy). Any Nationality

, Posted on May 30, 2018 1 Opening

Job Description

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Preparing the registration files for the MOH for new launches, and registration renewal applications to keep licenses valid.
• Put the annual registration submission plan with priorities based on the business plan and compliance obligations, which include clear objectives, target completion dates, with regular, follow up with CAPA.
• Participates in and follows up of different regulatory processes required for registration of the company s new products and maintenance of existing ones in the local and export market by ensuring timely submission of registration documents and formats as per the regulations.
• Keeping up-to-date with changes in regulatory legislation and guidelines and Ensures that the company strictly follows government rules and regulations.
• Preparing the registration files needed to register in different foreign countries in an efficient timely manner.
• Builds a strong relationship with other departments to form collaborative working teams and environment.
• Creates regulatory procedure/Standard Operating Procedures, as necessary.
• Review and approve product labels and promotional materials.
• Participate in product and/or regulatory teams to coordinate documentation.
• Product Technical File development and maintenance.

Industry Type : Medical / Healthcare / Diagnostics / Medical Devices
Functional Area : Doctor / Nurse / Paramedics / Hospital Technicians / Medical Research

Desired Candidate Profile

Bachelor of pharmaceutical /sciences/ or any medical related field
• 2-4 Years of experience in similar position (Medical background is preferred)
• Strong interpersonal skills with good communication skills
• Ability to manage multiple projects and deliver deadlines
• Team-working skills
• Attention to detail
• Ability to work under pressure
• Excellent command of the English language
• Excellent Computer skills (Word, Excel & PowerPoint).


Pharma Pharmacy Standard operating procedures Interpersonal skills Regulatory affairs MS Office Business planning Relationship Compliance Powerpoint

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Ameco Medical Industries

About this Company
Ameco Medical Industries is a medical group dealing in Catheters & Healthcare business since more than 12 years , and is being directed by physicians who had practiced medicine for quite a long time and who have got a high experience in the use of medical catheters.
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Medical Devices and Supplies
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