DRA Senior Associate, Gulf

Sandoz


Date: 3 weeks ago
City: Riyadh
Contract type: Full time
Job Description

  • 3 years’ experience in the regulatory field (new submission/ maintenance activity/ pricing) in assigned market(s).
  • Review and compile the registration dossier in cooperation with the Regulatory Competence Centre (RCC) department and the local relevant stakeholders to fulfil the local requirements and ensure smooth and rapid submission and approval of the files, in a timely manner, in line with the registration planning cascaded by the line manager and DRA Head.
  • Review and Validation of the promotional and educational materials against health authority regulations and approved product information and obtaining the authority approvals when applicable.
  • Communicate the deficiency letters raised by the health authorities to line manager and DRA Head and relevant global stakeholders during evaluation within the specified timeframe.
  • Ensure supply continuity of the registered products by securing the timely submissions and approvals of the variations and requesting special importation permit from HA when needed.
  • Maintain all market artworks in coordination with the labeling responsible and manufacturing site in alignment with the country regulations and approved product information.
  • Ensure execution of Pharmacovigilance and patient safety regulatory activities in compliance with the relevant SOPs and local HA regulations.
  • Ensure that product patient information leaflets are updated according to the latest CDS update approved in the country of origin by securing timely submission in alignment with the relevant SOP.
  • Complete and regular archiving the registration files, authorities correspondence and relevant documents.
  • Monthly reporting of the activity, regular and accurate updating of the tracking tools.
  • Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued by the health authorities, and immediate gap assessment and timely implementation within the company when applicable.
  • Contribution in overall strategy building, planning and execution of market activities to achieve the overall market(s) TGT and objectives.
  • Support in onboarding and guidance of any new joiners in GLS DRA team.

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Sales Capture Associate Director-Financial Services

Accenture Middle East, Riyadh
20 hours ago
As a Sales Capture Associate Director specializing in the Financial Services Industry with a focus on Banking, you will play a pivotal role in driving business growth by identifying, developing, and closing sales opportunities. You will collaborate with cross-functional teams to deliver tailored solutions that address the unique challenges and opportunities within the banking sector. Your expertise in financial services,...

SECONDARY ENGINEER

Larsen & Toubro, Riyadh
22 hours ago
Objective / PurposeAs a Design Engineer (Secondary), the person shall be capable of reviewing & executing Secondary Engineering Activities for Substation Projects as per the direction of Design Lead (Secondary). He must have good knowledge in Protection & Automation System in Substation. The person shall be thorough with protection applications. She / He shall coordinate with vendors for finalization of...

QC inspector - Mechanical

Larsen & Toubro, Riyadh
23 hours ago
Study the approved drawings, material/equipment approvals, and technical specifications, standards etc. required for the project and implement the same as applicable.Draft and finalize Project Quality Assurance Plan (PQAP) for the assigned projectEstablish Inspection and Test Plan (ITP) and checklists for various construction activities of project and ensure its implementation. Obtain customer approval of various quality documents from internal /customer representative...