Johnson & Johnson Careers
[Janssen] Regulatory Submissions Lead
Requisition ID: 1805635788W
& 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 health issues.
1. Job Title: Regulatory Submissions Lead
2. Sector: 한국얀센 (Janssen)
3. Location: Yongsan, Seoul
The Regulatory Submissions Lead is a member of the Regulatory Management Centre and is responsible for compilation of all life cycle management activities to regulatory agencies in Asia Pacific. The position reports to the RMC Submissions Manager.
- Facilitate discussion with the LOC on CMC variation / label change from global dispatch to local submission
- Connect with Global, Regional and Local RA colleagues on local dossier requirements
- Prepare submission plan based on global dispatch and country specific requirements
- Prepare submission-ready dossier based on local understanding and recipe book
- Work closely with LOC to ensure country specific inputs are updated into recipe book
- Request country specific documents such as data administration, translation, artwork, samples and certificate
- Manage and monitor HA query process
- Connect with RRL, Labeling team and LOC on content deviation process
- Work with Planning and Compliance team and Artwork team and LOC on post-approval activities
- University degree in pharmacy, life sciences or equivalent field
- 5 years or more relevant work experience in Regulatory Affairs/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies
- Experience of working in a virtual team and/or global organization
- Previous experience in RA role as Associate, Professional or similar role is of advantage
- Fluent in written and spoken English
- Knowledge of local regulations and international standards
- Able to make independent decisions
- Able to analyze (complex) information and situations and to formulate clear solutions.
- Constructive team player
- Good communication and collaboration required
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Janssen Korea, Ltd. (7220)