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.