Private Label

4 days ago


Jeddah, Makkah Province, Saudi Arabia Nahdi Medical Co. Full time
Accountabilities

JOB DESCRIPTION

  1. Responsible for high level communication and relationship with SFDA related to product and vendor registrations (Pharma and Front shop)
  2. Works closely with SFDA various departments ensuring strategic relationship for the company (Drugs, Medical Device, Cosmetics, Health/Herbal and Food sections)
  3. Delivering NPD (New product development) registration timeline on time in full and continuous improving of timelines efficiency
  4. 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.
  5. Responses to regulatory bodies inquiries (e.g. SFDA) and manages other correspondence in accordance with regulatory guidelines
  6. Manages and plans internal and external resources related to submission of various type of registration with SFDA and other stakeholders
  7. Supports PL and DI business by assessing opportunities for New Product Introduction
  8. Manages PL regulatory team and ensures continues development of talents
  9. Manages activities at a departmental level to fulfill both short & long term functional and business objectives.
  10. Monitors the progress of applications against set timelines, take necessary action to minimize delays and anticipate difficulties/challenges.
  11. Communicates information and presents status updates on product/project(s) to key internal/external stakeholders when requested.
  12. Ensures SOP and SLAs related to Department are in place and up to date
  13. Manages external consulting agencies to ensure that appropriate standards and timelines are met.
  14. 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
  1. Indoors: 80%
  2. Outdoors: 20%
  3. Working Days: 5 Working Days
  4. Days off: 2 Days Off
  5. Working Hours: 8:00 AM – 6:00 PM (1 hour break)
ExperienceJob Requirements
  1. BSc with Pharmaceutical or Medical background Education
  2. Min 8 years of Regulatory Affairs experience, must is experience working within Drugs and Health/Herbal sector
  3. Good communication skills, analytical, good knowledge of pharmacopoeias.
  4. Has experience with SFDA application platforms e.g., SDR, ECosma, GHAD, MDMA
  5. 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
  6. 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
  1. MS Office Suite
Languages
  1. English
  2. Arabic
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