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Regulatory Affairs Supervisor - MENA

Hikma Quality

Posted on August 10, 2018

1 - 2 years Amman - Jordan

Any Nationality

Opening 01

Job Description

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• Assure annual plan distribution and execution in terms of compliant submission excluding products with technical /administrative issues not taken into consideration upon preparation of the plan and supervise the preparing and sending responses to deficiency letters within NMT 5 working days from the date of receipt of required documents from other departments by the RA senior officer or RA officer
• Ensuring the implementation of required procedures for new product registration in MENA in order to attain regulatory approval within the required timeframe and maintaining the marketing authorization status with all necessary measures
• Supervise the build up and maintenance of the regulatory database and archives
• Training the teams on current and new regulations
• Supervise and support the preparation of up to date check list of requirements for all types of submission
• Follow up with the relevant departments to solve the technical issues to ensure the submission and execution of the plan on time
• Liaising with regulatory authorities and local entities in MENA to follow the submission of all files and documents where any Hikma Jordanian company is MAH
• Create, review and approve policies, procedures and checklists according to plan
• Create and implement a process to ensure that the plan 2Qs ahead is workable
• Research ways to decrease approval time by 10%
• JFDA experience preferred


Pharma / Biotech / Clinical Research

Corporate Planning / Consulting / Strategy / M&A

Desired Candidate Profile


BEHAVIOURAL COMPETENCIES
• Initiative & Drive for Results Level 1
• Customer Focus Internal/External Level 1
• Collaboration & Teamwork Level 1
• Change & Innovation Level 1
Education
BSc. in Pharmacy or Chemical Engineering

Keywords

Research Associate Administration Pharmacy Chemical Engineering Regulatory Affairs Supervisor Database Training Research Focus

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Hikma Quality


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