Regulatory Affairs Supervisor - MENA Hikma Quality Posted on August 10, 2018 1 - 2 years Amman - Jordan Any Nationality Send Me Jobs Like This SEND Alert Set Successfully Opening 01 Job Description EMAIL JOB SEND Email sent successfully. SHARE JOB • 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 Company Industry Pharma / Biotech / Clinical Research Department/Functional Area 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 REPORT THIS JOB Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information.We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at firstname.lastname@example.org People also searched for Supervisor Jobs Foreman Jobs Team Leader Jobs Consulting Jobs RA Jobs Chemical Engineering Jobs New Product Jobs Hikma Quality View Contact Details Contact Name/ Designation: - Website https://careers.hikma.com/en/jordan/jobs/regulatory-affairs-supervisor-mena-3765885/ Additional Information Required Employer has requested some additional information along with your application for this job Cancel Login to Naukrigulf Continue using GOOGLE FACEBOOK All your activity will remain private or Forgot Password?