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Achieve regulatory milestones within company determined timeline.\nCommunicate with global RA and other stakeholders\nPreparing registration dossiers and responses to questions from CDE and other related agencies\nFollow up registration procedure\nMake good relationship with officials/reviewers\nOrganize the preparation for CDE interactions (Pre-IND and Pre-NDA, etc.), include written consultation and panel meeting\nGet final registration permits\nGet related registration regulations knowledge and utilize in daily works\nSupport manager to provide RA input on the strategic planning for all responsible products\n Requirements\nAt least 8 years working experience in pharma Industry\nOver 6 years’ experience in RA field. Experience with ophthalmology products is preferred\nBachelor and above in medicine, pharmacy or related disciplines\nGood computer skill in EXCEL, POWERPOINT and WORD\nGood interpersonal communication skill\nGood English skills both in spoken and written\nAdditional location(s) Compensation Information:\nRequired Skills:\nDetail-Oriented, Global Communications, Pharmaceutical Regulatory Affairs, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory SubmissionsPreferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nSearch Firm Representatives Please Read Carefully\nMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. 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