Regulatory Affairs Specialist

Ameco Medical Industries - 10th Of Ramadan City, Sharqia

Applicants for
1 open position
Experience Needed:
2 to 4 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Arabic, English
1 open position
About the Job
  • 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.
Job Requirements
  • 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).
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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