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Regulatory Executive (For Cambodia)

FairDeal Co., Ltd

Regulatory Executive (For Cambodia)

FairDeal Co., Ltd
Recruiter active 2 hours ago The recruiter at this company was last active reviewing applications.
Myanmar - International
Full Time
Verified This job has been verified by the company as a real job vacancy.
13 Nov 2021

Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Min Education Level

Bachelor Degree

Job Description

Reports To

Regulatory   Executive   will report to MD   and Regulatory Manager.

Job Overview

  • Achieved DRCs, DIACs for pharmaceuticals, IRs and cosmetic notifications for FMCG products in FDA Cambodia.
  • Handling clients of 12 both pharmaceuticals and FMCG products across 9 countries in Asia and Europe.
  • Proficient in online submission for new registrations, gathering details and reviewing renewal requests.
  • Expedited for dossier checking and preparation for registration.
  • Managed for company registration and license application.

Responsibilities and Duties

-    Ensures compliance with all company procedures  / SOP’s and government regulations

  • ensuring compliance with regulations set by Cambodia FDA
  • planning, undertaking, and overseeing product trials and regulatory inspections
  • keeping up to date with changes in regulatory legislation and guidelines
  • offering advice about company policies, practices and systems
  • outlining requirements for labelling, storage and packaging
  • using a variety of specialist computer applications
  • liaising and negotiating with regulatory authorities
  • providing advice about regulations to manufacturers/scientists
  • ensuring that quality standards are met and submissions meet strict deadlines
  • preparing documentation for Registration, Import License 
  • reviewing and checking the validity date of product license
  • asking preapproval of registration fees from clients
  • analyzing the new products approval list of FDA- Cambodia  announcement
  • Every Saturday, WIP report to MD and regulatory Manager
  • Keep abreast of new product launches and ensure sales team members are on board
  • planning, undertaking, and overseeing product trials and regulatory inspections

 

Open To

Male/Female

Job Requirements

Qualifications and Experience

  • University Degree in Pharmaceutical Science or Science or related field
  • Four or more years experienced with regulatory affairs in the medical and pharmaceutical field
  • Language Skills and Other Skills

  • English
  • Computer Skills
  • Legal Knowledge skills
  • Management skills
  • Administrative skills
  • Communication Skills
  • Strategic Planning skills
  • Problem Solving skills
  • Technical Skills
  • Certificate, License, Others

    MS Office Suite, Adobe Photoshop CS3, Adobe PageMaker 7

What We Can Offer

Benefits

Bonus

Highlights

International Standard

Career Opportunities

Promotion Opportunity
management Potential

About Our Company

We understand the concept of optimum distribution critical for our each and every brand success in the market. With Yangon as Headquarter and Mandalay - Upper Myanmar regional office and stock points/depots in Upper & Lower Myanmar, our sales & marketing strong hold of over 300 people are effectively servicing the Universal Outlets. Hospitals and Clinics Super Markets Department Stores Traditional Retail Stores Market Stalls Wholesalers Mini Marts Pharmacies Restaurants & Hotels Currently, We cover approx 70% of all outlets. We cover 95% of all modern trade outlets

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Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Min Education Level

Bachelor Degree

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