GMP Compliance:

• Documentation:
  • Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016, ISO 15378:2017.
  • Write processes and procedures related to regulatory affairs department.
  • Archive all regulatory documentation including submissions and approvals in accordance with policies.
  • Update the registration list and status for all products.
• Regulatory Affairs activities:
  • Carry out all actions in accordance with written procedures and, where necessary, recorded.
  • Comply with the global strategy and objectives of the general management and organization.
  • Ensure that SP products comply with the Registration regulations of Lebanon.
  • Develop registration applications (Pharmaceutical and Pharmaceutical-Like) to be submitted locally and internationally.
  • Submit new registration applications and follow up on the appropriate licensing and regulatory compliance of pharmaceutical and/or medical products.
  • Collaborate with concerned internal departments to continuously develop the portfolio to meet local needs and ensure profit and growth to the company.
  • Develop professional relationships with governmental staff.
  • Apply for trademark s registration at the Ministry of Economy & Trade.
  • Ensure that all regulatory aspects of the applications at the Ministries level and other Governmental institutions are met within the requested time frame.
  • Attend authorities inspection of plant and premises.
  • Ensure timely Marketing Authorization Approval of the products submitted for registration.
  • Submit variations and pricing applications to the Ministry of Public Health and make the necessary follow-up till final approval.
  • Apply for the introduction of products in Hospitals and other institutions and make the necessary follow up till approval.
  • Apply for the expansion of the manufacturing site and any related division and follow up till approval and permit issuance
  • Apply for the certification and renewal of certification of the manufacturing site and follow up till approval and certificate issuance
  • Ensure compliance of the New Submission dossiers towards Export registration guidelines, and ensure proper dispatch to the concerned distributors in all countries, including communication to receiver and preparation of samples.
  • Actively follow up on registration development / applications status (through distributors and directly) till review of the applications and their final approval.
• Inter-departmental tasks:
  • Procurement: Assist in the clearance of goods through the control of shipping documents prior to their submission to Ministry of Public Health (MOPH) and through due follow up with the MOH when needed.
• ISO Compliance:
  • Report on the performance and opportunities for improvement of regulatory affairs process by monitoring achievement of its quality objectives and performance indicators.
  • Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
• Management:
  • Assure attainment of business objectives.
  • Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • Work closely with technical team (QC, QA& Production) on new investments, researches and documents preparation for products registration in potential countries.
• Others:
  • Accept and work any task related to regulatory affairs activity required by the Operations and Technical Manager.

Desired Candidate Profile

Fresh Graduate.