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Regulatory Affairs Executive

FairDeal Co., Ltd
Recruiter active 22 hours ago The recruiter at this company was last active reviewing applications.
Myanmar - Yangon
Full Time
Verified This job has been verified by the company as a real job vacancy.
16 Oct 2021

Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Min Education Level

Bachelor Degree

Job Description

Regulatory Affairs Executive

Reports To

Regulatory Affairs Executive will report to Assistant Regulatory Manager.

Job Summary

  • Achieved DRCs, DIACs for pharmaceuticals, IRs and cosmetic notifications for FMCG products in MMFDA.
  • Currently handling clients of 6 both pharmaceuticals and FMCG products across 5 countries in Asia and Europe.
  • Competent administrative professional supporting the underwriting process with effective document evaluation, report writing and file management skills.
  • Proficient in online submission for new registrations, gathering details and reviewing renewal requests.
  • Expedited for dossier checking and preparation for registration.

 

Responsibilities and Duties

Key duties of the job include:

  • studying scientific and legal documents
  • gathering, evaluating, organising, managing and collating information in a variety of formats
  • ensuring compliance with regulations set by Myanmar FDA (MM FDA)
  • maintaining familiarity with company product ranges
  • planning, undertaking and overseeing product trials and regulatory inspections
  • keeping up to date with changes in regulatory legislation and guidelines
  • analysing complicated information, including trial data
  • 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
  • writing comprehensible, user-friendly, clear product information leaflets and labels
  • ensuring that quality standards are met and submissions meet strict deadlines
  • preparing documentation for Registration, Import License and Retail License.

Open To

Male/Female

Job Requirements

Qualifications and Experience

  • University Degree in Pharmaceutical Science or Science or related field
  • Two 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

Management Potential
Learn new skills on the job

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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