Regulatory Affairs Specialist - Dubai, United Arab Emirates - Vieco Pharmaceuticals

Description

Company Description

Vieco Pharmaceuticals was founded in 2014 to provide high-quality medicines in the region while complying with the latest international regulatory standards. The company is young at heart and will play a significant role in improving the quality of local healthcare in the United Arab Emirates.

Role Description

1. Collaborate with different departments to collect the documents.
2. Review of documents received from different departments.
3. Maintenance of regulatory database up to date

4. Preparation of Artworks and dossier related sections.

5. Good knowledge of pharmaceutical products and its manufacturing process.

6. Must have knowledge on MOHAP and Dubai Municipality regulations .

7. Should have exposure on different kinds of formulations and its indications.

8.Hand in experience on Microsoft Word and Excel.

9.Handle Tuxedo software

Qualifications

1. Experience in Dossier preparation (M1-M5) in CTD and eCTD formats according to the country specific requirements.

2. Hands on experience in handling of eCTD software.

3. Experience in submitting the products for MOHAP and Dubai municipality registration.

4.Experience in the pharmaceutical industry.

5.Having knowledge on Pharmacovigilance (PV) is a must.