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Senior Regulatory Manager

Mega Lifesciences Ltd
Recruiter active 10 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.
3 days ago

Experience level

Manager

Job Function

Legal, Risk and Compliance

Min Education Level

Bachelor Degree

Job Description

  • Providing service about all regulatory matters especially on FDA guidelines & requirements 
  • Communication with principals for new, renewal registration & variation
  • Communication with FDA / TMO/ MPMEEA for DIAC, sales & warehouse license
  • Communication with responsible regulatory authorities (national/international) as well as with notified bodies
  • Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
  • Realising staff training on the topic of regulatory affairs
  • Staying informed about any changes in legislation etc.

Open To

Male/Female

Job Requirements

  • B.Pharm or related to pharmacy or medicine is preferable.
  • At least 3 years experience with related management level.
  • Well communication with government department
  • Management Skill
  • QA/ ISO compliance, training
  • Pharmacovigilance project (Training/site visit/ communication)

What We Can Offer

Benefits

-Yearly Bonus

-Yearly Salary Increment

-Medical Benefit

Highlights

- An awesome company
- Join a winning team
- You can make a difference

Career Opportunities

- Opportunities for promotion
- Possibility for job training
- Learn new skills and techniques

About Our Company

Established in 1983, Mega Lifesciences is engaged in manufacturing, marketing, selling and distribution of Medicines – Nutritional, Herbal, OTC – drugs & Prescription – drugs in developing countries. Mega Lifesciences is committed to provide quality products & services to our customers & consumers through constant improvement and innovation. Mega Lifesciences is a Thinking Organization that changes before it is forced to change & endeavor to grow beyond each of us.

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