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Senior Regulatory Affairs Specialist

Johnson & Johnson

Senior Regulatory Affairs Specialist

Johnson & Johnson

Hong Kong, Hong Kong

·

On-site

·

Full-time

·

4d ago

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group:

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Hong Kong, Hong Kong

Job Description:

  • Take charge of all regulatory submission dossier preparation

  • Timely prepare responses to regulatory agencies questions and other correspondences

  • Be accountable to obtain on track approvals of new registration/change with high quality; and ensure the renewal approvals 100% on time prior to license expires.

  • Maintains the RA database, records and archives all regulatory documentation

  • Timely respond product registration related inquiries from government & customers

  • Review artwork & packaging & labeling, as required.

  • Keep up to date with government legislation as it relates to JNJ, provides implications/interpretations and recommend actions

  • Coordination of promotional material review and approval

  • Support HK tendering documents

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

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About Johnson & Johnson

Johnson & Johnson

Caring for the world, one person at a time.

10000+

Employees

New Brunswick

Headquarters

Reviews

3.6

5 reviews

Work Life Balance

3.8

Compensation

2.5

Culture

3.0

Career

3.2

Management

2.8

45%

Recommend to a Friend

Pros

Good work-life balance

Strong R&D division

University talent engagement

Cons

Contract employee job security issues

Pay cuts during transitions

Product liability concerns

Salary Ranges

2,248 data points

Mid/L4

Senior/L5

Director

Mid/L4 · Manager

338 reports

$155,591

total / year

Base

$137,488

Stock

-

Bonus

$18,103

$106,549

$229,934

Interview Experience

7 interviews

Difficulty

3.0

/ 5

Duration

14-28 weeks

Experience

Positive 0%

Neutral 86%

Negative 14%

Interview Process

1

Application Review

2

HireVue Video Interview

3

Recruiter Screen

4

Technical/Hiring Manager Interview

5

Panel Interview

6

Offer

Common Questions

Behavioral/STAR

Technical Knowledge

Past Experience

Culture Fit

Case Study