Supervisor, Regulatory Affairs in Hikma Pharmaceuticals 2022 at Khartoum, Sudan

Website Hikma Pharmaceuticals

This Job Listing is about Hikma Pharmaceuticals in Khartoum, Sudan 2022
Job description:

    • Implements approved departmental policies and procedures and ensures adherence with the processes implemented so that work is carried out in a controlled manner.
    • Implements the day-to-day operations of the section by providing guidance, encouraging teamwork and facilitating related professional work processes in order to achieve high performance standards.
    • Supervises the activities and work to ensure that all work within a specific area is carried out in an efficient manner and in compliance with the set policies, processes, and procedures.
    • Participates in the process of developing department procedures and contributing to the development of policies for the development of the department work and activities.
    • Follow up regularly with authorities, internal departments and external on related submissions and files to ensure meeting deadlines and negotiate with health authorities regarding the registration requirements to enhance execution of Hikma’s planned submission strategies.
    • Review, analyze and approve reports.
    • Handles complex projects to ensure project targets are met properly.
    • Provide feedback in the 5-YBP on registration pathways, timelines and risks in relevant supervised territory.
    • Generate annual registration plans covering new product registration and all maintenance of registrations required per territory.
    • Generate and monitor the monthly plan execution.
    • Evaluate files from Regulatory point of view internal and external.
    • Update and train concerned departments on new regulations regarding drug authorization.
    • Communicates regularly with external agencies to manage any related arrangements that would facilitate the files submissions/approvals
    • Participates in the development and / or develops, monitors the implementation of functional policies and procedures to ensure all relevant procedural/legislative requirements are fulfilled.
    • Complies with all relevant safety, quality, health and environmental procedures to ensure a healthy and safe work environment.

Qualifications:

  1. Education
    • BSc. or higher in Pharmacy.
    • Sudanese Medical Council Registration.
  2. Experience
    • 05 – 07 years of related experience.
  1. Behavioral Competencies
    • Collaboration and Teamwork.
    • Planning and Organizing.
    • Taking Initiative and Drive for Results.
    • Developing and Empowering Others.
    • Instill Trust.
    • Customer Focus Internal/External.

Company: Hikma Pharmaceuticals

Vacancy Type: Full Time 

Job Location:  Khartoum, Sudan

Application Deadline: N/A

Apply Here

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