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[Korea] RA manager
79% Flex
EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE
Remote:
Full Remote
Experience:
Senior (5-10 years)
Work from:
South Korea
Job description
Your missions
Job Description
The local RA manager is assigned to multiple products and could support other projects led in RA department.
- Ensure timely registration of new products and maintenance of approved products
- Local coordination and execution of regulatory submission in compliance with internal standards and local regulatory requirements
- Develop and execute registration strategies
- Lead the labelling & promotional material review & approval process
- Monitor and analyses changes in relevant local regulations, guidelines and regulatory environments
- Comply with all local regulations while executing the assigned roles and responsibilities as defined in the local regulations, guidelines etc.
Qualifications
- More than 5 years experiences in local RA fields
- Depth knowledge of local legislation and regulations relating to medicinal products.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Depth understanding of the registration procedures and challenges in local for NDA and all activities for lifecycle managements
- Various knowledges and experiences in local regulatory environment for development of new products and registration of them
- Good negotiation skills & communication skills
Additional Information
- Having experiences on medical devices is preferable.
- A pharmacist is preferable, but not limited.
Required profile
Experience
Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory. Hard Skills
Soft Skills
- Negotiation
- Interpersonal Skills
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