(ÁÖ)¼¼Á¾¾¾¾Ë¿À´Â Ç×¾ÏÁ¦ Àü¹® CROÀÌ¸ç ´Ù±¹ÀûÀÓ»óÀ» ÁøÇàÇÏ°í ÀÖ½À´Ï´Ù. ¸¹Àº ºÐµéÀÇ Áö¿ø ºÎŹµå¸³´Ï´Ù.
✔ Job Description
- To maintain and strengthen communication with KFDA
- Review, analyze and co-ordinate data for new product submissions
- Develop registration strategies, implement regulatory plan and co-ordinate multiple projects and activities in accordance with strategic company objectives.
- Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
- Maintain the registration of marketed products.
1) Support Regulatory Affairs Manager to develop assigned product specific plans and registration strategies
* Analyze regulatory and product information
* Define and anticipate potential issues
2) Achieve timely registration of new products and clinical study authorization approval
* Prepare and submit registration dossier in accordance with the plan
* Communicate effectively with the Agency, HQ and appropriate experts
3) Maintain and update registration status of marketed products
* Discuss appropriate filing timeline with related departments
* Interact with the Agency proactively
4) Review artworks
* Review local artworks to ensure that they are in accordance with the relevant regulation or guidelines
✔ Job Requirements
- Above bachelor's degree (Pharmacist preferred)
- Minimum 1 years experienced in regulatory affairs (RA) in pharmaceutical company
- Public affairs, policy and government agencies experiences plus
- Strong interpersonal and relationship building, communication skill with internal & external customers
- RA ¾÷¹«¸¦ ÃÑ°ý management ÇÒ ¼ö ÀÖ´Â ºÐ
- 4³âÁ¦ ´ëÁ¹ ÀÌ»ó (¾àÇÐ, °£È£ÇÐ, »ý¸í°øÇÐ µî °ü·ÃÇаú ¿ì´ë)
- ¿µ¾î communication ´É·ÂÀÚ ¿ì´ë
- MS Office ´É¼÷ÀÚ
- Good of Documentation skills
✔ Additional Information
- Ä¿¸®¾î¼öÁØ : RA (´ë¸®)
- ±Þ¿©»çÇ× : ¸éÁ¢ ÈÄ ÇùÀÇ
- °í¿ëÇüÅ : °æ·Â Á¤±ÔÁ÷
✔ Guidelines for Applicants
- ÀüÇü¹æ¹ý : 1Â÷ ¼·ùÀüÇü/2Â÷ ¸éÁ¢ÀüÇü
- Á¦Ãâ¼·ù : ±¹¹®/¿µ¹® À̷¼ (°æ·ÂÁß½É)(°¢Á¾ Áõºù¼·ù´Â ÃÖÁ¾ÇÕ°ÝÀÚ¿¡ ÇÑÇØ ÃßÈÄÁ¦Ãâ)
- Á¢¼ö¹æ¹ý : À̸ÞÀÏ : gmansh@sjcro.com / Homepage : http://www.sjcro.com
✔ Contact Information
- ¸¶°¨ÀÏ : 8¿ù 7ÀϱîÁö
- ä¿ë´ã´ç : ±èÇÐÀ± ¿¬±¸¿ø
Tel :02)521-3778,3779 / Mobile : 010-2377-0608 / Fax :02)521-3776
- Homepage : http://www.sjcro.com
- E-mail (Company): gmansh@sjcro.com
- ÁÖ¼Ò : ¼¿ï ¼Ãʱ¸ ¼Ãʵ¿ 1319-11 µÎ»êº£¾î½ºÅÚ 806È£
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