Export Assistant-Logistic Department

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

Role Summary

Responsible to ensure continuous timely support of required technical and administrative documentation for respective APIs / DSs / RMs to warrant that Jamjoom Pharma product submissions are complying with the guidelines and meeting the timelines as per the annual registration plan through healthy relationships, strong follow-up with internal and international departments, regulatory associates, and respective active substance manufacturers/vendors/suppliers.

Responsibilities

• Maintaining the life cycle of Drug Master Files from respective API / DS manufacturers/suppliers by direct communication or through JP appointed agents and guide their regulatory team for Review / Correction and Life Cycle management of the Drug Master File for all the existing/commercial and new products of JP local and export portfolio.
• Accountable for the planning and prioritization of the DMFs as per the yearly plan.
• Handle and Sign the MRF (Material request form) from R&D and ensure that the concerned documents are in place and queries (if any) are settled before signing the MRF.
• Responsible to provide technical assistance to the team to review CMC-related activities of API/DS part including process chemistry and synthesis route development, manufacturing chemistry, controls, etc., and associated documents provided in the Drug master files.
• Keeping track of the ever-changing legislation/regulations/directives/guidelines in all the regions in which the company wishes to register/distribute / market/sell its products and keep pace with the ongoing guidelines.
• To meet the timelines and manage delays, negotiate delivery timelines, and cater to efficient information flow between internal and external teams/stakeholders.
• To understand and analyze scientific data, and results and review scientific documents in the DMFs procured from the API/DS Suppliers.
• Reviewing queries & deficiencies for submitted products for a timely response.
• Ensure effective coordination and follow-up with RA associates in local and/or international to facilitate communication in matters relating to product registration submission and approvals.

Qualifications

• Saudi National is preferred.
• Minimum 2 to 4 years of experience in the relevant field.
• Expert regulatory and scientific knowledge for product registration, renewal of marketing authorizations, and variations as per current regulations in Saudi Arabia, GCC, and other countries.
• Excellent oral and written communication and presentation skills.
• Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
• Proficient computer skills including MS Office, RIS, eCTD, and SAP.