JOB PURPOSE
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- Ensure that product registration or business licenses are obtained and maintained in line with the business plan
- Ensure that regulatory strategy is set-up in align with GRA strategy
- Ensure that product registration is maintained in compliance with regulatory requirements
KEY ACCOUNTABILITIES:
Product Registration & Maintenance
: Set up registration strategy and timeline according to the launch strategy of NME
- Develop bridging data to obtain marketing authorization from Ministry of Food and Drug Safety (MFDS) in collaboration with Global Regulatory Affairs and Medical.
- Prepare MFDS application according to the local regulation/requirements/SOP and ensure filings and approval.
- Secure product license by updating CMC, CCDS and safety information.
- Review promotional materials to comply with local regulation and Sanofi SOP.
- Manage business licenses appropriately.
- Regulatory Intelligence and policy shaping in align with Sanofi strategy
- Provide relevant regulatory consultation and insight to internal functions.
- Collaborate with other functions for cross-functional projects based on regulatory environment.
- Establish and maintain effective working relationships with internal and external stakeholders
JOB-HOLDER REQUIREMENTS:
[Education]
University degree in Life science or pharmacist
[Experience & knowledge]
- More than 2-3 years’ experience in regulatory affairs in pharmaceutical industry
- Good knowledge of regulations of pharmaceutical affairs
- Comprehensive knowledge in pharmacy
[Core competencies /skills]
- Strategic planning skill
- Good communication & interpersonal skills
- Strong collaborative ability and dedication to team accomplishment
- Drive to succeed (individually and as a team) with a strong work ethic
- Fluent in professional environments (written & verbal) in both English and Korean
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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