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Regulatory Affair Specialist

DKT International

Regulatory Affair Specialist

DKT International
Recruiter active 4 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.
27 Jul 2020

Experience level

Experienced Non-Manager

Job Function

Procurement, Supply Chain

Min Education Level

Bachelor Degree

Job Description

About the job: Regulatory Affair Specialist, reporting to Supply Chain Manager, is responsible for the regulatory affairs for all DKT products; Kiss condoms, Mojo condoms and Lydia female contraceptives.

- Handling regulatory affairs for all DKT products, including registrations, licenses and renewals with FDA

- Collaborate with other units, especially, Sales and Marketing to ensure the compliance in packaging and labelling processes for all products

- Maintain the relationship with external parties, including ministries, distributors and agencies

- Ensure all the changes in rules, regulations and processes are keeping up to date

- Ensure all the documents are kept in systematic order

- Performing other tasks assigned by direct supervisor.

 

Open To

Male/Female

Job Requirements

- University Degree in any disciplines (B. Pharm, MBBS or other medical background is preferable)

- Minimum 2 years' experience in regulatory affairs of medical products

- Pharmaceutical background experience is a must.

- Good understanding of Myanmar Regulations from FDA, MOHS, MMC & MMA with basic marketing knowledge

- Ability to use Microsoft Office (especially Microsoft excel)

- Good command of writing and speaking in both English and Myanmar Languages

- Ability to work in multicultural environment

- Ability to travel frequently.

 

What We Can Offer

Benefits

*Yearly Bonus

Highlights

We are on the lookout not just for talent, but also for friends and partners for the long term.

Career Opportunities

*Learn new skills on the job

About Our Company

DKT International is a social marketing organization whose core mission is the provision of safe and affordable options for family planning and HIV prevention.

DKT Myanmar is one of the largest private providers of contraceptives and reproductive health products and service providers in the country. We deploy social marketing strategies to increase couples' access to and use of high-quality, affordable contraception and reproductive health technology and products. You can find more of our work at www.dktinternational.org.

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