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

Job Description
Overall purpose of job:

• Coordinates, compiles, and submits or guide the coordination, compilation and submission of new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.
• Manage and lead Regulatory Affairs Team (where applicable)
• Essential duties and responsibilities:
• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares or guide the preparation of responses to regulatory agencies' questions and other correspondence.
• Guide or gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Organizes and maintains reporting schedules for new drug application and investigational new drug applications
• Supervises and develops registration strategies on new products.
• Supervises and develops timelines for submissions under the direction of senior regulatory affairs staff.
• Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables.
• Provides regulatory advice to project teams.
• Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
• Comply with integrity and compliance standards.

Job Requirements
Essential knowledge and skills:

• Bachelor’s degree or above in Science
• Proficiency in both spoken and written English and Chinese
• Generally requires 6+ years related and reputable experience in healthcare sector with regulatory affairs experience

Core competencies required for this role: 
Essential – Communication Skills, Market Knowledge, Business Relationship, Project Management, Regulatory Environment, Reimbursement, Planning & Organization, Research & Analysis, Science & Therapeutic Knowledge, Strategic Thinking

Important – Interpersonal skills, Ability to manage multiple projects, Coaching & Mentoring, Training & Development, HR Management & Motivation

Attitudes/Personality - Influencing, Independent, Team-player, Creative

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.

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.