Johnson & Johnson Careers
[Janssen] - Regulatory Affairs Specialist
Requisition ID: 1905717518W
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 health issues.
PURPOSE OF POSITION
Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
- Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Conducts searches of existing files for requested information.
- Support the development of registration strategies on new products
- Support the development of timelines for submissions under the direction of senior regulatory affairs staff.
- Maintains and archives all regulatory documentation
- Comply with integrity and compliance standards
- Bachelor Degree or above
- For Regulatory Affairs Specialist, minimum 2 years solid and reputable experience in regulatory affairs
- Proficiency in both spoken and written English and Chinese
- Communication Skills
- Market Knowledge
- Business Relationship
- Project Management
- Regulatory Environment
- Interpersonal skills
- Ability to manage multiple project
China-Hong Kong S.A.R.-Mongkok-
Johnson & Johnson (Hong Kong) Ltd. (8060)