Opening for Regulatory Affairs (Formulations) at Riyadh Pharma | Saudi Arabia
The Pharmaceutical manufacturing facility of the Medical and Cosmetic Products Company Limited has been established on a 15,000 square meters site in Riyadh's 3rd Industrial Area. Riyadh Pharma is the Company's brand name. As we are in the way for establishing a robust R&D department in Riyadhpharma factory, equipped with all resources (machines, Laboratories, manpower, IT access) which will help in executing all the new products submitted by the high management, in addition to the improving process of the existing products in a programmatic attitude.
Post: Regulatory Affairs (Formulations)
• Preparation, Review and submission of Technical documents/Dossiers (CTD/eCTD) related to Regulatory affairs of Pharmaceuticals Formulations.
• Preparing checklist for all new product filing, collecting, reviewing the data & screening for compilation. Preparation of MIS with regard to filings. Storage & archiving of all data & files pertaining to new product registrations, existing products.
• Registration for import of pharmaceuticals Formulations and bulk drugs.
• M.Pharm/ B.Pharm / M. Sc. Chemistry/ Ph.D with 5+yrs exp in preparing dossier in formulation for pharma
• Checking/reviewing of documents as per regulatory requirements. Maintenance of lists/documents/records. Co-ordinate with QA/production. Perform as per regulatory filing plan.
• Excellent command over written and verbal English communication. Must be proficient in computer skills and business communication. Should be self-motivated and result oriented.
• Must have been through a minimum of 2 successful submittals of eCTD.
Experience: 5+ years
Location: Saudi Arabia
Education: B.Pharm, M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
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