Quality & Regulatory Affair specialist

Company : Adecco

Job Type : Full Time

United Arab Emirates, United Arab Emirates

Number of Applicants

:

000+

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Job Description - Quality & Regulatory Affair specialist

Quality & Regulatory Affair specialist

Find your next role with Adecco! We are the world's leading workforce solutions company, offering Flexible Placement, Permanent Placement, Executive Search, Emiratization, Outsourcing and Volume Hiring Services Across All Sectors.

Adecco Middle East is hiring Quality & Regulatory Affair specialist for one of our reputed clients based in Dubai .

Job Type: 12 months extended contract.
Job Location: Dubai, UAE (Onsite)

Job Responsibilities:

With moderate supervision, responsible for the following Regulatory and Quality activities.
Develop and implement regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards.
Prepare documentation to support product registration and modifications according to project phase implementation.
Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in EMEA countries.
Provide Regulatory intelligence.
Support communication with our local agent and distributors in EMEA countries.
Act as QRA representative in the project implementation and work activity with various stakeholders
Notification to the regional quality and regulatory team for sharing status & update of ongoing project.
Monitoring of local Regulatory Environment, and new regulations and support feed-back and gap assessments to International Regulatory Departments and business partners that impact the project.
Ensure follow-up/improvement of the distribution control procedure.
Responsible for the maintenance and archiving of all regulatory documentation in the region.
Where needed, support the reporting of Serious Adverse Events to Competent Authority(ies) in EMEA.
Responsible for ensuring compliance with Quality Procedures, Laws, and Regulations of the applicable markets.
Communicate business related issues or opportunities to next management level.
Ensure personal and Company compliance with all local and Company regulations, policies, and procedures
Responsible of the training and deployment of local tools related to distribution control
Ensure QRA administrative tasks related to assigned project are completed
Perform other duties assigned as needed

Skills and Qualifications:

BA/BS in Scientific discipline or equivalent work experience (2 years min)
BS degree in Pharmacy, Medicine, Physical or Biological science or similar obtained by experience
Minimum of 2 years’ experience in Regulatory and/or Quality
Consistent background and knowledge of MD regulations.
Must be proficient with MS Office applications
Excellent communication skills (verbal and written)
Must be familiar with distribution activity.
Experience with QRA warehousing management
Project management skills preferred
Due to nature of job role and its responsibilities candidates fluent in Arabic are preferred

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