𝐄𝐱𝐩𝐨𝐫𝐭 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬 𝐒𝐮𝐩𝐞𝐫𝐯𝐢𝐬𝐨𝐫
Full time posted 6 days ago in Regulatory Shortlist Email JobJob Detail
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Job ID 31765
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Career Level Experienced Non-Manager
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Education Level Bachelor\'s Degree
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Industry Pharmaceutical
Job Description
- Prepare and maintain required documentations needed for the registration of company products.
- Coordinate with EDA; Egyptian Drug Authority, to ensure compliance with all regulations and laws as necessary, follow-up with submitted documentations and resolve any issued that may arise.
- Prepare the registration documentations needed to register in different foreign countries in an effectively and timely manner.
- Keep up-to-date with changes in regulatory legislation and guidelines and ensure company compliance with government rules and regulations.
Requirements:
- Bachelor’s degree in Pharmacy is a must.
- 3-5 years of experience in the pharmaceutical sector.
- Expert in CTD files and e-CTD preparation and reviewing registration dossiers (countries specialized dossier or CTD).
- Strong knowledge of the regulatory framework of international pharma legislation, relevant guideline, procedures &requirements.
- Awareness of preparing submissions of license variations and renewals.
- Proficiency in spoken and written English and prepared little French language.
- Excellent communication and presentation skills.
- Excellent Time management skills.
Required skills
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