[ȸ»ç¼Ò°³] https://www.msd-korea.com/
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RA Specialist(Associate) 2¸í (±Ù¹« ½ÃÀÛ ~ 2021³â 1¿ù±îÁö±Ù¹«/»êÈÞ´ëü)
[HR Talk]
Çѱ¹ MSDÀÇ ÀÎÇã°¡ ÆÀ¿¡¼ ±Ù¹«ÇØÁÖ½Ç ºÐÀ» ¸ðÁýÇÏ°íÀÖ½À´Ï´Ù.
½ÅÀÔ Áö¿ø °¡´É(¾àÇÐ Àü°øÀÚ ¿ì´ë)Çϸç, RA °æ·Â ¿ì´ëÇÕ´Ï´Ù. Áö¿øÀ» Èñ¸ÁÇϽô ºÐ²²¼´Â ¾Æ·¡ÀÇÁö¿ø¹æ¹ýÀ» Âü°íÇϼż Áö¿øÇØÁÖ¼¼¿ä.
[Responsibilities]
Obtain the regulatoryapproval timely through the best registration strategy, maintain productlicense with local regulation and global compliance standard.
1.Achieve timelyregistration of new products and their variations/updates
-Prepare and submitregistration dossier in accordance with the plan
-Communicate effectivelywith the Agency, HQ and appropriate experts
2.Support RegulatoryAffairs Manager to develop assigned product specific plans and registrationstrategies
-Analyze regulatory andproduct information
-Define and anticipatepotential issues
3.Maintain productlicenses
-Update safety andquality information timely
-Meet the compliance forglobal RA database
-Follow up post-approvalactivities (re-examination, DMF, annual report, etc.)
[Qualification]
¡¤ 4³âÁ¦ Á¹¾÷, ½ÅÀÔ Áö¿ø °¡´É(¾àÇРȤÀº °ü·Ã Àü°øÀÚ)
¡¤ RA°æ·Â(½Ç½ÀÆ÷ÇÔ) ¿ì´ë, QA/Clinical Trials/PV/Medical field °æ·Â °í·Á
¡¤ Functional Knowledge: Drug Development, Local/Global regulatoryenvironment, Structure or functions of pharmaceutical industry
¡¤ Strategic focus, Communication & Negotiation, Projectmanagement Skills, Coaching skills, Fluent written & spoken English
[Áö¿ø¹æ¹ý] ¾Æ·¡ÀÇ ¸µÅ©·Î ÀÚÀ¯À̷¼¸¦ ÷ºÎÇÏ¿© Áö¿øÇØÁÖ¼¼¿ä
https://msd.wd5.myworkdayjobs.com/SearchJobs/job/KOR---Seoul---Seoul-Square/RA-associate-specialist_R18160
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-Áö¿ø ½Ã ÆÄÀÏÀº Çϳª·Î ÅëÇÕÇÏ¿© PDF, WordÆÄÀÏ·ÎÁö¿øºÎŹµå¸³´Ï´Ù.
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-±âŸ¹®ÀÇ»çÇ×ÀºE-mail(minjung.choi@merck.com)·Î ¹®Àǹٶø´Ï´Ù.