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Regulatory Affairs Manager

Talent Experts
| ရန်ကုန်တိုင်း
Verified This job has been verified by the company as a real job vacancy.
17 Jun 2019
Recruiter active 1 day ago The recruiter at this company was last active reviewing applications.
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Regulatory Affairs Manager

Talent Experts

Regulatory Affairs Manager

Talent Experts
Recruiter active 1 day ago The recruiter at this company was last active reviewing applications.
Myanmar - ရန်ကုန်တိုင်း
Verified This job has been verified by the company as a real job vacancy.

လုပ္သက္အဆင့္

Manager

အလုပ္အမ်ိဳးအစား

Legal, Risk and Compliance

Job Industry

လူ့သုံးကုန်ပစ္စည်းထုတ်လုပ်ဖြန့်ဖြူးရောင်းချမှု

အနိမ့္ဆံုး ပညာအရည္အခ်င္း

Bachelor Degree

Job Type

Full Time

လုပ္ေဆာင္ရမည့္တာ၀န္မ်ား

A Fantastic Opportunity for ...

• Effectively implement the company QA, SHE and REG policies and standards, guarantee the regulatory compliance to local and international laws and regulations in all concerned areas
• Account for all administrative matters such as budget, expenses, travel approvals, holidays etc.
• Act as first RA contact person in the country
• Report on local RA activity
• Report on critical deviations and claims
• Implement RA guidelines and procedures
• Coordinate RA activities among RA and Specialist Lines (QA, SHE, REG)
• Implement internal QA rules and coordinate QA activities in the Country
• Audit existing processes and improve QA standards in the Country
• Set up and standardize local QA process, guarantee full compliance of all goods, integrated with global QA and whole RA system
• Audit suppliers, forwarders, Elaborate, review, check and communicate QA related documents (reports, specifications, etc.)
• Elaborate, review and check classification of a chemical according to the chemical and transport regulations in place (Global Harmonized System for classification and labeling and the ADR, IATA, IMDG) along with the material creation process in SAP
• Harmonize classifications with SHE managers abroad
• Create and maintain the Safety Data Sheet of a chemical
• Keep informed about local, national, international legislation, including updates and revisions
• Inform local employees about the legislation
• Support requests for information from internal and external contacts according to corporate policies and procedures
• Maintain familiarity with local government regulations, policies and guidelines
• Visit conferences and local associations
• Prepare budget costs for registration and get internal approval for registration
• Ensure that all required elements for regulatory / registration filing are scheduled correctly and in place to meet the target filing, registration dates and the budget

Open To

Male/Female

လိုအပ္ေသာအရည္အခ်င္း

• Bachelor or Master Degree in Chemistry, Pharma or otherwise experienced and qualified
• Good knowledge of Quality Management System
• At least 5 years of experience in RA
• Strong communication skills
• English is a must (both written and spoken)
• Additional languages of the Region or country are an advantage

What We Can Offer

အက်ိဳးအျမတ္

• Rewards for over performance

ထူးျခားခ်က္မ်ား

• International working environment

အခြင့္အလမ္းမ်ား

• Promotions opportunities
OR

လုပ္သက္အဆင့္

Manager

အလုပ္အမ်ိဳးအစား

Legal, Risk and Compliance

Job Industry

လူ့သုံးကုန်ပစ္စည်းထုတ်လုပ်ဖြန့်ဖြူးရောင်းချမှု

အနိမ့္ဆံုး ပညာအရည္အခ်င္း

Bachelor Degree

Job Type

Full Time

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