Importation and Release Senior Specialist

About the job

JOB PURPOSE:

• Securing importation approvals for name patient basis products (SILs) for non-registered products
• Responsible for the handling all types of HAs inspection Visits (Finished goods, promotional materials , medical samples,...etc) including samples withdrawal & final release reports.
• Update the importer registers on a timely manner.
  

KEY RESPONSIBILITIES AND DUTIES:

Planning:

• Preparation of the regulatory documents required for submission of the annual / complementary Importation Licenses and or importation approvals of companyProducts and working closely with the DRA / GRA team to ensure that the documents are valid and complete at the time of submission (CPPs, registration licenses, pricing certificates, variations approvals, etc.)
• Working with different internal stakeholders in order to receive the documents required for issuing special import licenses for non-registered products (SILs) on timely manner.
  

Submission:

• Filling in all MOH forms and templates required for submission.
• Submission of the importation plans / approvals together with all the related documents to the concerned departments at MOH (Registration department – licensing department – importation department).
• Submission of SILs requests to MOH
• Following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders
  

Inspection & Release:

• Follow up on inspection and release visits.
• Tracking & following up the status of CPPs & GMPs required for batch release.
• Regularly update the relevant archiving tools and local trackers.
• Working closely with supply chain and DRA release colleagues and providing support to ensure final release / inspection of the upcoming shipments are done on timely manner.
• Responsible for the handling all types of HAs inspection Visits (Finished goods, promotional materials, medical samples,...etc) including samples withdrawal & final release reports.
  

Others:

• Perform other duties as assigned.
• Respect of company’s values, code of ethics and social charter.
• Respect of personal data protection charter.
  

Responsible for applying the HSE related requirements for the company in all related working procedures.

JOB-HOLDER’s ENTRY REQUIREMENTS: "

Education:

• Bachelor of Pharmaceutical Sciences
  

Related Experience:

• Total Experience of minimum 3 years of Regulatory experience
• Importation experience is essential
  

Special Knowledge/Skills:

• Computer Skills, Negotiation & Communication Skills.
• Good planning and organization skills
• Good Command of English Language
  

Competencies Requirement

• Stretch to go beyond the level we have operated at up until now.
• Take action instead of waiting to be told what to do.
• Act in the interest of our patients & customers.
• Put the interests of the organization ahead of my own or those of our team.