[Responsibilities]
1. Review dossier and check feasibility to get MA and/or DMF for drug products and drug substances.
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2. Proceed pre-review application (specification & test method and/or safety & efficacy) to confirm feasibility.
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3. Setting-up regulatory strategy through dossier review regarding new project.
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4. Conduct IND submissions and hand it according to project plan in timely manner.
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5. Communication with MFDS and suppliers to prepare queries and deficiencies(S&T, S&E and GMP).
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6. Time-line checking of launch preparation: artwork, registration for ID code, pricing and barcode etc.
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7. Perform to proceed MA variation according to change control from QA or toll manufacturer.Ç°Áú°ü¸®ÆÀ ¶Ç´Â ¼öŹ»ç·ÎºÎÅÍ º¯°æ°ü¸® ÀÚ·á Á¢¼ö ÈÄ Çã°¡º¯°æ ÁøÇà
8. Manage MA renewal based on MA expiry date and re-evaluation of products
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9. Timely updating of internal database
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10. Check and follow up pharmaceutical regulations and MFDS notification frequently.
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11. Participate in TFT, seminar, news and training related with regulation and job.
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12. Review the protocol and report of PMS(Post-Marketing Surveillance)/RMP(Risk Management Plan)
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[Qualifications]
1. An advanced degree is required in chemistry, biology, biochemistry or pharmacy (preferred).
2. Business level of English (both Speaking & Writing)
3. 5~7 or more years of pharmaceutical experience is preferred.
4. Good knowledge of pharmaceuticals related regulations
5. Ability to manage multiple assignments simultaneously, work independently and as part of a team.
6. Requires initiative
7. Good ability in searching and interpreting medical literature.
8. Good interpersonal and team skills with ability to build consensus.
9. Results-oriented work ethic.
10. Strategic problem solving skills.
11. Highly motivated with high personal and ethical standards
12. Cross-Functional Collaboration for Common Goal
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003