Job Seeker Reactivate Your Account
Thank you, this account has been Deactivated.
Do you want to Reactivate your account?
No
Yes

Regulatory Affairs Executive

FairDeal Co., Ltd
Thaketa | Yangon
Verified This job has been verified by the company as a real job vacancy.
16 Oct 2021
Recruiter active 18 hours ago The recruiter at this company was last active reviewing applications.
Sorry, Unable to Apply
x
55%
Please Upload CV Attachment, or update your JobNet Profile to at least 55% of completion.
Upload CV
Update Profile
Regulatory Affairs Executive
FairDeal Co., Ltd, Thaketa | Yangon

Regulatory Affairs Executive

FairDeal Co., Ltd

Regulatory Affairs Executive

FairDeal Co., Ltd
Recruiter active 18 hours ago The recruiter at this company was last active reviewing applications.
Myanmar - Yangon
Verified This job has been verified by the company as a real job vacancy.

Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Job Industry

Pharmaceutical/Life Sciences

Min Education Level

Bachelor Degree

Job Type

Full Time

Job Description

A Big Opportunity for ...

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