Regulatory Affairs Associate
|담당업무|| [Purpose of Job]|
The Regulatory Affairs Associate is responsible for assisting in timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements.
[KEY Accountabilities and Responsibilities]
- Assists in obtaining marketing approval from the KFDA for a planned new drug(K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA).
- Contributes to the effective and efficient initiation of clinical trials with the company's investigational new drug through supporting for K-IND submission and approval.
- Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
- Provides regulatory affairs related information to other departments.
- Assists Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (KFDA, MOHW, KJPA etc.)
- Assists Regulatory Affairs Manager for coordinating regulatory activities among departments (Marketing, Business Development etc.) and timely communications with TGRD, TPC and Millenium.
- Assisits Regulatory Affairs Manager to develop new product registration strategy.
(Essential responsibilities :
1. Registration feasibility pre-review
2. Preparation of K-NDA or K-IND files
3. DMF and/or GMP site inspection
4. Maintenance and update of registered products
5. Product label management
6. Interactions with TGRD
7. Other duties as assigned
|경력|| - 2+ years experience in pharmaceuticals with at least 2 years in RA|
- Must be degree qualified, pharmacy
- Proven ability to build and maintain relations with internal as well as external customers
- Good project management skills and effective communication skills
|연령||30세 전후 선호|
|제출서류||국문이력서(구체적인 경력기술 포함)|