ㆍ경력 : 경력 7년 ~ 10년
ABOUT ABBOTT :
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Established Pharmaceuticals
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
Primary Job Function:
- Registering new products and managing existing products by leveraging a current and changing regulatory environment.
- Liaising, responding to, and negotiating with regulatory authorities.
- Support business planning activities by providing of smart registration strategy.
- Compliant with the current Abbott procedure.
- Leading regulatory compliance management.
Core Job Responsibilities:
- Achieve registration approval for planned new products and ensure subsequent maintenance of existing drugs on time.
- Provide the best registration strategy and timeline and communicate it with stakeholders.
- Secure product license maintenance according to local regulations and global Abbott compliance standards.
- Understand the regulatory environment changes and prepare for the implementation in compliance with the new regulation and Abbott procedures.
- Provide proper and exact Regulatory related information to stakeholders.
- Maintain well-managed external communication with related Health Authorities.
- Review registration requirements upon request by internal stakeholders.
- Leading regulatory compliance management: regular monitoring & implementing actions for RA systems as trainer level. Analyzing regulations and environment, and keeping stakeholders updated.
Position Accountability / Scope:
- Product/Business license registration, maintenance, and relevant regulatory activities for Pharmaceutical Products (chemical & biologics).
- Communication with the global and local stakeholders regarding the RA topics.
- Promotional material review for the assigned products.
- Compliance with the Abbott procedures, performing the related activities.
Minimum Education required:
Bachelor’s degree or above (Major: Pharmacy preferred, or other related majors)
Minimum Experience/Knowledge required:
- 7 years of experience in RA areas of the pharmaceutical industry.
- Multinational Company experience preferred.
- Good knowledge of the laws and regulations governing RA areas.
- Advanced level of communication in English.
