[Job Description]
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. Conduct IND submissions and hand it according to project plan in timely manner.
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4. Communication with MFDS and suppliers to prepare queries and deficiencies(S&T, S&E and GMP).
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5. Artwork, registration for ID code
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6. Perform to proceed MA variation according to change control from QA or toll manufacturer.
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7. Proceed MA renewal based on MA expiry date and re-evaluation of products
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8. Timely updating of internal database
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9. Participate in TFT, seminar, news and training related with regulation and job.
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[Requirements]
1. An advanced degree is required in chemistry, biology, biochemistry or pharmacy (preferred).
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2. New comer or 1~3 years of pharmaceutical experience is preferred.
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3. Good interpersonal and team skills with ability to build consensus.
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