채용공고
제목 Regulatory Affairs Manager_Consumer Health Division
모집기간 2017-11-30 ~ 2017-12-14 상태 모집중 온라인 입사지원
모집부서 Regulatory Affairs in Pharmaceuticals
업무개요

1. Regulatory affairs
-Maintain and strengthen communication with MFDS(Ministry of Food and Drug Safety)
-Review, analyze and co-ordinate data for new product submissions
-Develop registration strategies, implement regulatory plans and co-ordinate multiple projects and activities in accordance with company’s strategic objectives.
-Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals
-Maintain the registration of marketed products.
-Provide regulatory inputs and supports for marketing plans, product launches and other cross-functional activities
-Monitor and disseminate information on changes to pharmaceutical regulations affecting registration, manufacturing, distribution and products sales
-Demonstrate strong leadership and influence for KPMA and KRPIA activities in order to achieve improvements in industry operating environment
- Assess suitability/effectiveness of local SOP and OIs reflecting current regulation and HA practice and lead to amend local SOP and OIs to ensure control of up-to-date local SOP and OIs
- Keep regulatory database completely updated

2. Local manufacturing
-Look for local companies to be able to manufacture healthy food supplement products
-Develop local healthy food supplement products complying with Korean Regulation









응시자격

EDUCATION :
-University degree and above
-Preferred Major / Area of Study: Pharmacy
-Preferred License: Pharmacist

EXPERIENCE :
-Experiences in Regulatory Affairs
-At least 5 year-experiences of Regulatory Affairs is preferred

PERSON SPECIFICATIONS
-Good knowledge and understanding of relevant Pharmaceutical laws and drug products
-Good relationship with internal and external personnel
-Good negotiation and communication skill to effectively partner with Health authorities
-Positive attitude and result-oriented mindset
-Strategic thinking
-High standard in verbal and written English