Export Regulatory Affairs Specialist
Full time posted 1 year ago in Regulatory Shortlist Email JobJob Detail
-
Job ID 16741
-
Career Level Entry Level/Junior Level / Fresh Grad
-
Education Level Bachelor\'s Degree
-
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.
Job Requirements:
Bachelor’s degree in Pharmacy is a must.
- 1-3 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.
- Problem solving and strategic planning skills.
Required skills
Other jobs you may like
-
Regulatory Affairs Specialist
- Cairo, 36 El-Sheikh Mohamed El-Nady St., Nasr City, 11371