Janssen, a division of Johnson & Johnson (HK) Ltd. is recruiting for a Regulatory Affairs Specialist, located in Hong Kong

Job Description

Essential duties and responsibilities:

• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses to regulatory agencies' questions and other correspondence.
• Organizes and maintains reporting schedules for CORP submission, 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.
• Maintains and archives all regulatory documentation
• Comply with integrity and compliance standards.

Job Requirements

• Essential knowledge and skills:
• Bachelor’s 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
• Core competencies required for this role:

Essential –

Communication Skills, Market Knowledge, Business Relationship, 

Project Management, Regulatory Environment, Reimbursement

Important –

Interpersonal skills, Ability to manage multiple projects

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

How to Apply:

If you are keen to take up the challenges, please click "apply now". You will be redirected to J&J careers website to complete online applicant process and online Credo Assessment.

You would be invited to an online digital interview recording once your applicant is suitable for this position. 

Personal data provided by job applicants will be used for recruitment purpose only.Candidates who are not being invited for interviews within four weeks may consider their applications unsuccessful. All applications will be kept for maximum of six months as future reference for similar openings.