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Expected Areas of Competence
Products registration and the life cycle management of existingproducts with timeline
Registration planning with regulatory strategy
Preparation of regulatorydocuments and submissions
Take part inregulatory agency inspections
Liaising, responding to inquiries from regulatory agencies and negotiating with regulatory authorities
Co-work with internal stakeholders and global RA
Monitor the regulatory environment and implement in a timelymanner
Identify relevantguidance documents and provide interpretive assistance to the relavant internalfunctions
Experiences desired
Documentation, submission ofproduct registration file for Generic products and/or new products.
Experience in localbioequivalence study
Participatation in GMP, DMFinspection
Qualification,
¤·Pharmacist / ÀϹÝÀü°øÀÚ °øÈ÷ Áö¿ø °¡´É
3~10 years experienceof RA in pharmaceuticals.
Over anintermediate level(Áß»óÁ¤µµ) of written and spoken english
Good interpersonal & communication skills
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