Regulatory Affairs Specialist
Rameda -
Cairo, EgyptPosted 8 years ago233Applicants for1 open position
- 26Viewed
- 16In Consideration
- 1Not Selected
Job Details
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Job Description
- Repairing 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 effectively timely manner .
- Builds 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 is a Must
- 0-3 years of experience ( Fresh Graduates are welcomed )
- 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).
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