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Recruiter active 2 days 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.
6 days ago

Experience level

Experienced Non-Manager

Job Function

Medical, Nursing, Pharmacy

Min Education Level

Bachelor Degree

Job Description

  • Ensure to follow up the regulatory staff regarding medical device registration rules and regulation changes and report promptly to Regulatory Manager
  • Ensure timely preparation and compilation of registration documents (New and renewal) as per FDA guideline and get filing documents confirmation approval from Manager before submitting to FDA
  • Submit the products for NHL test and ensure to obtain NHL approval in advance (one month) before proceeding products registertion submission to FDA.
  • Follow up registration process status and requirements with regulatory staff to avoid delay in achieving IR approval on time.
  • Keep up to date registration process status record and report manager on daily basis.
  • Double check the product detailed information in Orginal IR and request approval from Manager to hand over IR (Original) to related deparments Manager.
  • Ensure keeping handover documents record
  • Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities

Open To

Male/Female

Job Requirements

  • Relevant degrees such as Chemistry, physics, biochemistry, pharmacy, applied sciences
  • Minimum experience 2 years and above in related field
  • Basic knowledge of local regulatory affairs rules and regulation
  • Good communication skills are required to communicate with related government department.
  • Ability to maintain healthly relationship with government stakeholders
  • Time management and well organize skills are are key factors in regulatory affairs department for all the registration processes are on track.
  • IT skills is required to obtain Online Booking Appointment for product registration submission purposes.

 

What We Can Offer

Benefits

- Yearly Bonus

Highlights

- Fun working environment

Career Opportunities

- Learn new skills on the job
- Training Provided

About Our Company

Established in 1996, AA Medical is Myanmar's largest and most trusted pharmaceutical distribution company with branch offices throughout the country, as well as oversea subsidiaries in Singapore and the United States.

In our desire to serve the healthcare requirements of the people of Myanmar better, we focus on the registration, distribution, sales, marketing, and market research development of quality products.

OUR STRENGTHS ARE:
More than 1200 a strong workforce that consists of employees our 15 offices throughout Myanmar
The reputation being Myanmar's widest distribution reach, with a fleet of over 160 vehicles serving over 18,000 outlets coverage to pharmacies, hospitals, clinics, and drug stores
Air shipment capability for the urgent delivery of lifesaving drugs
Quality products that comply with international standards of safety and efficacy
Proven partnership success with our partners for distribution, marketing, and regulatory compliance