Private Label

**Accountabilities**
- Responsible for high level communication and relationship with SFDA related to product and vendor registrations (Pharma and Front shop)
- Works closely with SFDA various departments ensuring strategic relationship for the company (Drugs, Medical Device, Cosmetics, Health/Herbal and Food sections)
- Delivering NPD (New product development) registration timeline on time in full and continuous improving of timelines efficiency
- Understands the regulatory landscape in KSA. Monitors the regulatory environment and provides assessment of the impact of new and changing regulations on the company’s areas of interest.
- Responses to regulatory bodies inquiries (e.g. SFDA) and manages other correspondence in accordance with regulatory guidelines
- Manages and plans internal and external resources related to submission of various type of registration with SFDA and other stakeholders
- Supports PL and DI business by assessing opportunities for New Product Introduction
- Manages PL regulatory team and ensures continues development of talents
- Manages activities at a departmental level to fulfill both short & long term functional and business objectives.
- Communicates information and presents status updates on product/project(s) to key internal/external stakeholders when requested.
- Ensures SOP and SLAs related to Department are in place and up to date
- Manages external consulting agencies to ensure that appropriate standards and timelines are met.
- Manages allocated registration and 3rd party budgets (OPEX)

Employee duties are not limited only to the above-mentioned Accountabilities; he/she may perform other duties as assigned.

**Work Environment**
- Indoors : 80 %
- Outdoors : 20 %
- Working Days : 5 Working Days
- Days off : 2 Days Off
- Working Hours : 8:00 AM - 6:00 PM (1 hour break)

**Job Requirements**

Experience
- BSc with Pharmaceutical or Medical background Education
- Min 8 years of Regulatory Affairs experience, must is experience working within Drugs and Health/Herbal sector
- Good communication skills, analytical, good knowledge of pharmacopoeias.
- Familiar with regulatory framework in KSA related to SFDA for different health practices; regulatory affairs & registration, export-import/clearance procedure, experienced with diverse sectors i.e. Pharma, Food, Medical devices
- Familiar with global standards of registration dossiers and other technical provisional file supportive elements, such as e-CTD, cGMP, Pricing, CPPs/FSCs, Conformity Bodies. Pharmaceutical market understanding is an advantage

Computer Skills
- MS Office Suite

Languages
- English
- Arabic