Johnson & Johnson Careers
[Janssen] Sr. RA Specialist
Requisition ID: 1905774857W
Johnson & Johnson is the world's most
comprehensive and broadly based healthcare Company, touching the lives of
nearly a billion people every day. Our Family of Companies throughout the world
compete in consumer, pharmaceutical, and medical devices and diagnostics
markets and have the skills and resources to tackle the world's most pressing
- 계열사: 한국얀센 (Janssen)
- 포지션: Sr. Regulatory Affairs Specialist
- 근무지: 서울시 용산구
- 근무형태: 계약직 (Fixed term)
To register products in a timely manner in support of business growth and to maintain full compliance of products with regulatory requirements
1) Prepare submissions for the new product registration.
2) Maintain a close working relationship with Government authorities (KFDA, Testing Agencies) for the product registration.
3) Initiate, track and facilitate new product registrations in Korea and achieve on-time approvals
4) Maintain regulatory compliance of registered products.
5) Proactively renew licenses to avoid business interruptions
6) Coordinate documents compiling and perform all regulatory assessments with Global RA.
7) Monitor regulatory environment changes, and provide impact analysis plus action plans to ensure compliance Interaction with local regulatory authorities, experts, and industry groups to drive new guidelines / regulation toward harmonized international standards
8) Provide regulatory input to the relevant functions (Marketing, Sales, etc.) for developing new projects and variation in existing products.
9) Communicate local environment change and registration status to local, regional, and global stakeholders.
- A Minimum of a Bachelor's degree in a scientific/technical/engineering /pharmaceutical /discipline is required
- A minimum of 5 years of working experience within the Pharmaceutical Regulatory environment writing regulatory submissions is preferred
- Pharmacist is highly preferred
- Expert knowledge, understanding and application of principles, concepts and practices of government regulations are required.
- Expert regulatory knowledge to maintain legal status of products and minimize risk.
- Ability to organize and analyze data and identify issues or gaps is required.
- Broad based technical knowledge in diverse areas of business. (e.g. R&D, Operations, QA, laboratories, marketing, etc.)
- Demonstrated ability to develop & execute innovative solutions within the boundaries of regulation.
- Strong communication, organizational, negotiation and interpersonal skills are required.
- Strong verbal and written communication skills in English & Korean.
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[For more Johnson & Johnson]
- J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/
- J&J Korea Linkedin: https://www.linkedin.com/in/country-recruiter-talent-acquisition-296167147/
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Janssen Korea, Ltd. (7220)