Regulatory Affairs Specialist

1 week ago

Alexandria, Alexandria, Egypt Vitabiotics Egypt Full time $30,000 - $60,000 per year

𝐕𝐈𝐓𝐀𝐁𝐈𝐎𝐓𝐈𝐂𝐒 – 𝐄𝐠𝐲𝐩𝐭 for pharmaceutical industries is looking to hire the following position:

"
Regulatory Affairs Specialist
"

Location: Al Sheikh Zayed, Cairo, Egypt

Job role

Ensure product registration and regulatory processes, ensuring timely approvals, certificate renewals, and compliance with local authorities

Duties and Responsibilities

1.    Prepare the registration and licensing process for products with EDA, including dossier preparation, submission, fee payment, and appointment coordination, as directed by the Direct manager.

2.    Handle all CADC-related procedures, including sample submission, fee payment, appointment scheduling, follow-up on analysis progress, and appropriate reporting of results.

3.    Monitor and report updates to registration guidelines and regulatory requirements as announced by relevant authorities.

4.    Prepare NFSA registration files and supporting documents in accordance with requests from the Registration & Regulatory Affairs Supervisor or Manager, ensuring accuracy and adherence to regulatory requirements.

5.    Compile and prepare all necessary documentation for license renewals, whether for facilities or products in alignment with regulatory requirements and under the guidance of the direct Manager.

6.    Execute all assigned registration and regulatory tasks in full compliance with established Standard Operating Procedures (SOPs).

7.    Has appropriate knowledge about CTD preparation. Previous courses and export work are preferred.

𝐣𝐨𝐛 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭:

·       Bachelor's degree of Pharmaceutical Science or Science

· to 3 years' experience in pharmaceutical Industry

·       Deep understanding of pharmaceutical quality standards

·       Strong attention to detail and excellent analytical skills

·       Effective communication and collaboration abilities

𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗰𝗮𝗻𝗱𝗶𝗱𝗮𝘁𝗲𝘀 𝗺𝗮𝘆 𝗮𝗽𝗽𝗹𝘆 𝗯𝘆 𝘀𝗲𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲𝗶𝗿 𝗿𝗲𝘀𝘂𝗺𝗲𝘀 𝘁𝗼

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𝗮𝗻𝗱 𝗱𝗼𝗻'𝘁 𝗳𝗼𝗿𝗴𝗲𝘁 𝘁𝗼 𝗺𝗲𝗻𝘁𝗶𝗼𝗻 𝘁𝗵𝗲 𝗷𝗼𝗯 𝘁𝗶𝘁𝗹𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗮𝗶𝗹 𝘀𝘂𝗯𝗷𝗲𝗰𝘁.

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