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Position Summary:
- Execute regulatory activities from policy to completion.
- Provide guidance for the decision making process relating to regulatory issues.
- Manage Regulatory submissions for all products in responsible countries.
- Compile information from multiple sources for regulatory filing, writing summaries
and other necessary documentation.
Essential Duties and Responsibilities:
1. Make a plan for the product approval and maintain the marketing authorization
including PMS study, variations, annual reports and any regulatory process for both
stages of pre-approval and post-approval.
2. Execute preparations of the application files and follow ups for marketing
authorization approval.
3. Effectively manage project timelines as defined by department and corporate
objectives.
4. Monitor Korean regulations and trend of global regulations and standards to ensure
that Company systems comply with requirements for import and distribution of
pharmaceuticals, medical devices, functional food and cosmetics, ensuring
compliance with the most stringent applicable laws and regulations.
5. Participate in third party audits of the GMP, and assist with coordinating,
compiling, and submitting responses to any observations made during those audits.
6. Review and approval of documentation for regulatory compliance, including product,
process and software validation.
Position Requirements :
1. Pharmacist license is required
2. At least 4 years experience in a lead regulatory role at pharmaceutical company
3. Pharmaceutical drug registration experience is mandatory
4. Excellent interpersonal skills.
5. ¿µ¾î °¡´ÉÇϽŠºÐ
´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ ¿øÇö¼÷»ó¹«(
www.mstone.co.kr
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¿¬¶ôó : 02-2050-0299, 010-8911-5018
À̸ÞÀÏ :
hs@mstone.co.kr
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02-2050-0299
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02-2050-0296
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