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Regulatory Affairs Specialist

Client of Manpower Middle East

Posted on July 5, 2018

1 - 2 years Other - United Arab Emirates

Any Graduation. Any Nationality

Opening 01

Job Description

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This is a Contract role with Manpower.
Regulatory Affairs Specialist
Job Summary:
Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products registration/notification, renewals and updates by coordinating between internal and external stakeholders and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals. The Specialist will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.
Responsibilities Include:
Ensure timely registration/notification and renewal of products, Keep and maintain files and documents regarding product regulatory and compliance. Support global initiatives.
Develop and maintain a product database of all products regulatory status in the region and ongoing registration.
Plan and execute local projects and programs to meet technical and business needs within areas of responsibility based on annual performance, corporate and regional goals.
Efficiently manage timelines (submissions to approval) to cope with regional and local projects & strategies as well as marketing plans through proactive communications with all relevant parties including country/region leader, RA, R&D, Marketing, Supply Chain, Sales and any other functions.
Establish and maintain good relationships with Ministry of Health, Emirates Authority for Standardization and Metrology, Dubai Municipality, any other Regulatory authorities and industry associations, ensuring optimum visibility and smooth products registration.
To maintain detailed knowledge, documentation of the legislation, monitor possible changes and influence changes that apply to: Chemical product hazard communication; Chemical product transportation classifications including air, ground and water; any other changes in non-registered chemical product compliance requirements affecting our company's products being commercialized in the country/countries.
Write department reports, give internal presentation and prepare reports for distribution outside of the department, communicate at all levels of the company on matters of expertise. Give presentations to technical business management and write reports addressing business/compliance /policy issues
Degree, Certification, Training and Language Preference/ Requirement
Bachelor of Science (BSc)
Fluent in English and Arabic (speak and write)
Able to clearly express oneself orally and in writing. Effective and routinely communication at department level and with business managers.
Hands-on and able to work independently. Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.
Extensive knowledge of RA environment (processes, organization, legislation) in the ME.
Must have strong collaborations skills, the ability to work in a cross-cultural organization and experience working in a partnership environment.
Strong mental agility and motivation are required to deal with the variety of product categories and market access strategies.
Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach and ability to build relationship with external contacts.


Pharma / Biotech / Clinical Research

Administration

Desired Candidate Profile

Job Summary:
Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products registration/notification, renewals and updates by coordinating between internal and external stakeholders and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals. The Specialist will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.
Responsibilities Include:
Ensure timely registration/notification and renewal of products, Keep and maintain files and documents regarding product regulatory and compliance. Support global initiatives.
Develop and maintain a product database of all products regulatory status in the region and ongoing registration.
Plan and execute local projects and programs to meet technical and business needs within areas of responsibility based on annual performance, corporate and regional goals.
Efficiently manage timelines (submissions to approval) to cope with regional and local projects & strategies as well as marketing plans through proactive communications with all relevant parties including country/region leader, RA, R&D, Marketing, Supply Chain, Sales and any other functions.
Establish and maintain good relationships with Ministry of Health, Emirates Authority for Standardization and Metrology, Dubai Municipality, any other Regulatory authorities and industry associations, ensuring optimum visibility and smooth products registration.
To maintain detailed knowledge, documentation of the legislation, monitor possible changes and influence changes that apply to: Chemical product hazard communication; Chemical product transportation classifications including air, ground and water; any other changes in non-registered chemical product compliance requirements affecting our company's products being commercialized in the country/countries.
Write department reports, give internal presentation and prepare reports for distribution outside of the department, communicate at all levels of the company on matters of expertise. Give presentations to technical business management and write reports addressing business/compliance /policy issues
Degree, Certification, Training and Language Preference/ Requirement
Bachelor of Science (BSc)
Fluent in English and Arabic (speak and write)
Able to clearly express oneself orally and in writing. Effective and routinely communication at department level and with business managers.
Hands-on and able to work independently. Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.
Extensive knowledge of RA environment (processes, organization, legislation) in the ME.
Must have strong collaborations skills, the ability to work in a cross-cultural organization and experience working in a partnership environment.
Strong mental agility and motivation are required to deal with the variety of product categories and market access strategies.
Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach and ability to build relationship with external contacts.

Keywords

Supply Chain Research Associate Metrology Interpersonal Skillsiness Management Regulatory Affairs Relationship Compliance Corporate Database

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Client of Manpower Middle East

ManpowerGroup is a leading global name in innovative workforce solutions and caters to the human resource requirements of both small and large organizations across various industries. Founded in 1948, ManpowerGroup has expanded its reach from one office to a strong international network of 3, 500 of fices in 80 countries. The company involves working with over 400,000 clients and 304 million associates every year and assists them in increasing the productivity of their businesses by providing them with human resource and services like training & development, recruitment & assessment, career management and workforce consulting.



The company has a vision to be a leader in the creation and delivery of innovative workforce solutions and services. The Group cares about its people and offers them various opportunities to develop their careers through proper training and planning.

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