RA IND Specialist or RA IND Senior Specialist is responsible for getting IND approval in Korea within a planned timeline and taking the most appropriate actions to keep the clinical development in compliant with government regulations and company procedures including Good Regulatory Practice (GRP).
Typical Accountabilities
CTA/Product registration & maintenance
- Prepare for clinical trial applications (IND or IND variation) according to the local and global strategy in collaboration with SM&M Korea.
- Implement/manage registration procedures required by Korean pharmaceutical regulations to achieve the earliest market entry.
- Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue. Update the safety information in line with the CDS and other reference countries.
- Product lifecycle maintenance: Keep product license to be compliant with regulations.
Product QA
- Package compliance: Secure the package compliance in line with the local regulation and AZ compliance.
- Quality Control: Give advice to the QC lab based on regulatory knowledge and support the technical transfer.
- Responsible for company’s compliance into all relevant Korean and AZ’s procedure including Good Regulatory Practice (GRP).
- Review the compliance of promotional literatures from regulatory perspective.
Relationship with customers (internal & external)
- Maintain high level of authorities’ satisfaction through application of high professional standard in all contacts, quick resolution of authorities’ enquiries and provision of support.
- Maintain positive relationship with local contractors, customers and internal staff.
- Comply with the relevant regulations and AZK’s ethical business practices with full understanding of the code of conducts.
Intelligence Gathering
- Get any information relating to changes in the relevant regulatory regulations and health authorities and report to RA manager on any expected impact on our business.
- Develop/maintain good relationship with government agencies and regulatory bodies to achieve above.
Skills
- Sufficient regulatory knowledge and experience
- Good command of spoken and written English
Qualifications
- Education: BA or MA biology-related science (pharmacy preferred)
- Language: Korean and English
- Work Experience: Regulatory experience for 1 year minimum, Pharma industry experience 1- 5 years
- Competencies: Experience of working on cross-functional teams & Knowledge of the drug development process
※ Global Career Level can be changed depending on candidate's experiences.
Date Posted
18-4월-2024
Closing Date
17-7월-2024
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Read Full Description