One of our clients which is local pharmaceutical company is looking for a Regulatory
Team Leader as follow;
*Job Title : Regulatory (RA) Team Leader
*Position : Section Manager ( Kwajang or Chajang)
*Target Age : Late ¡®30s Early 35¡¯s
*Gender : Female or Male
*Location : Gangnam Seochodong.
*Limited to pharmaceutical industry field
*PURPOSE & RESPONSIBILITIES;
-Reporting to department of business development director.
-To study, plan, manage, coordinate regulatory issues in Korea and provide regulatory guidance for pharmaceutical affairs including product transaction in the Generic and Over-The-Counter brand market.
-KFDA guidelines, KFDA regulation, SOP preparation and update well clinical
practices phase1,phase2.phase3.phase 4.skills with an ability to adapt.
-To study, plan product commercialization.
-Review and study regulatory feasibility including price feasibility
-Develop regulatory strategy for prospective products including regulatory timeframe.
-Propose regulatory services to principals
-Provide regulatory requirements for Principals
-Existing permit product management
-Keep update the regulatory issues for pharmaceuticals and medical devices and manage
the risk factors
-Communicate with internal staffs related to the each project to keep the regulation
-Initiate project from registration timeframe
-Study market feasibility /price feasibility
-Communicate with principals and initiate & coordinate contract issue
-Art work ; Labeling and packaging materials selection and design tasks, and working
for packages.
.
*REQUIREMENT ;
-BS/MS Degree in pharmacy or equivalent non Pharmacist (¾à»çÀÚ°ÝÁõ ¾ø¾îµµ µÊ )
-Minimum 6~7 years solid experienced in only Regulatory (RA) for middle level pharmacy
products company.
-Multinational Pharma company experience preferred
*SKILL;
-A strong communication leadership Regulatory knowledge.
-Negotiation skill to KFDA and aggressiveness.
-Accustomed to working project teams and providing research with advice for compliance
with laws to regulatory guidelines.
-Excellent presentation & facilitation skills.
-Excellent interpersonal skills, advance level of enthusiasm and self motivation.
-Good manner, good chemistry.
-Multi-functional Team work & good relationship.
-Basic written and spoken English.
-Proficiency Ms -Office, Excel, PowerPoint, and internet etc.
*Salary; Negotiable
*Those who are interested in this opportunity, please contact us submit your
resume in English by e-mail. (MS Word only). ASAP
I will keep my fingers crossed for you !
# STRICTLY PRIVATE & CONFIDENTIAL ! #
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