[PURPOSE OF POSITON/ROLE]
The Regulatory Affairs Manager is responsible for all aspects of the regulatory process in compliance with regulatory requirement for K-NDA and K-IND including supplemental and amended K-NDA from filing to post approval. Regulatory Affairs Manager plays a key integral role to coordinate the process of registration of new products and maintenance of approved products and assists to RA Director in making of key business decisions in the process.
[KEY ACCOUNTABILITIES AND RESPONSIBILITIES]
- Develops registration stragegies, implement regulatory plan and co-ordinate multiple projects and activities in accordance with strategic company objectives
- Monitor and assesses impact of new regulations on local procedures and product development strategies.
- Contributes to the effective and efficient initiation of clinical trials with the company's investigational drug through supporting the study strategy for registration.
- Obtains approval from the KFDA for a planned new drug (NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended NDA).
- Ensures registered products are maintained and updated in full compliance with all relevant legislation and TAKEDA procedures.
- Provides regulatory input, competitor intelligence and support for marketing plan, products launches and other cross-functional activies and facilitates timely communications with TDC, TPC and global RA team
- Establishes, develops and maintains close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KJPA etc.) to facilitate and positively influence all regulatory interactions.
- Manages/trains and develops regulatory affairs associates
- Support the regulatory directo to ensure local Quality Assurance in complaint with local regulation and Takeda SOPs
A. Essential responsibilities –
1. Develops registration strategies by reviewing data and facilitating the commnucation with TDC and TPC
2. Manages the product registration approval including new product, new indication and line extension
3. Manages all the registered product in compliance with regulatory requirement and regulatory action
4. Being fully aware of the regulatory environment
5. Liaison regulatory activities between TAKEDA and TDC
6. To maintain and strengthen communication with MFDS and relevant authorities
B. Marginal responsibilities –
1. Gathering regulatory intelligence for competitors
2. Managing and training regulatory associate
3. Cooperation with pharmaceutical industry associations (e.g. KJPA regulatory affairs committee) for influencing positively to regulatory authorities
4. Making sure for local QA test to be timely prepared and performed for seamless product supply
|근무지||서울 강남구 대치동|
|처우조건||면접후 협의(업계 상위 수준)|
|학력||대학교 약학과 졸업 (약사 필수)|
|경력||관련 경력10년 이상, 다국적 제약사 경력 필수|
매니저(people managing) 경력 선호
매니저 경력 선호하나, 매니저 경력이 없는 경우에도 지원 가능
|연령||40대 초중반 선호|
|특기사항||비즈니스 영어 가능자(글로벌 커뮤니케이션 등)|
|제출서류||국문이력서(구체적인 경력기술 포함)|