Regulatory Affairs Expert

4 days ago

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

We are seeking a highly skilled and experienced Regulatory Affairs Expert to join our team at Nahdi Medical Co. as a Private Label & Directly Imported Pharma Brands Department Manager.

About the Role
  • This is a key position responsible for managing high-level communication and relationships with regulatory bodies, including the Saudi Food and Drug Authority (SFDA), to ensure timely product and vendor registrations.
  • The successful candidate will work closely with SFDA departments to maintain strategic relationships, drive business growth, and deliver new product development (NPD) registration timelines on time.
  • They will monitor the regulatory landscape in KSA, providing assessments of the impact of new and changing regulations on the company's areas of interest.

In this role, you will respond to regulatory inquiries, manage internal and external resources, and support the PL and DI business by identifying opportunities for New Product Introduction.

Key Responsibilities
  1. Manage high-level communication and relationship with SFDA related to product and vendor registrations.
  2. Work closely with SFDA various departments ensuring strategic relationship for the company.
  3. Deliver NPD registration timeline on time in full and continuous improving of timelines efficiency.
  4. Understand the regulatory landscape in KSA. Monitor the regulatory environment and provide assessment of the impact of new and changing regulations on the company's areas of interest.
  5. Respond 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. Monitors the progress of applications against set timelines, take necessary action to minimize delays and anticipate difficulties/challenges.
  10. Communicates information and presents status updates on product/project(s) to key internal/external stakeholders when requested.
  11. Ensures SOP and SLAs related to Department are in place and up to date.
  12. Manages external consulting agencies to ensure that appropriate standards and timelines are met.
  13. Manages allocated registration and 3rd party budgets (OPEX).

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