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Senior Regulatory Affairs Manager

Abbott

Senior Regulatory Affairs Manager

Abbott

China - Beijing

·

On-site

·

Full-time

·

2w ago

Benefits & Perks

Healthcare

401(k)

Learning Budget

Career Development

Healthcare

401k

Learning

Required Skills

Regulatory Affairs

Regulatory strategy

China regulatory knowledge

Global regulatory frameworks

Analytical skills

Communication

JOB DESCRIPTION:Responsibilities:

  • Collaborate closely with global and local teams to develop and implement regulatory strategies for assigned projects, including business development initiatives.
  • Continuously monitor and analyze the regulatory environment in China as well as major global agencies (FDA, EMA, PMDA). Translate insights into innovative and actionable regulatory strategy.
  • Build strong relationships with internal stakeholders across Regulatory, CMC, Clinical Operations, Medical, Quality, Business Units, Market Access, and Commercial teams. Integrate regulatory intelligence and business insights into strategic decision-making. Provide regulatory support for Abbott’s planning in business, market access, commercial activities, and quality assessments.
  • Represent Abbott in interactions with regulatory authorities, industry associations, and working groups to support advocacy initiatives aligned with company priorities. Lead and maintain effective communication with regulatory agencies and external consultants.

Supervisory/Management Responsibilities:

Direct Reports:      0-2

Minimum Education:

  • A Master’s degree or above in pharmacy, biology, chemistry, pharmacology or related life sciences is required

Minimum Experience/Training Required:

  • Industry experiences: A minimum of 8 years’ experience required in Regulatory

  • Position experiences:

  • Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.

  • Deep expertise with global regulatory frameworks (NMPA, FDA, EU/EMA, PMDA, etc.) .

  • Prior experience supporting drug development lifecycle—from development through submission and post-approval.

  • Strong analytical capabilities to assess complex regulatory information and translate it into strategic recommendations.

  • Excellent communication, presentation, and interpersonal skills with the ability to influence without direct authority.

  • Experience in Woman Health, Gastro, Liver, CV, Urology, CNS, Vaccine, etc.  is a plus

The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma:

LOCATION:

China > Beijing : Canway Building

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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About Abbott

Abbott

Abbott

Public

Abbott is a global healthcare company that develops medical devices, diagnostics, branded generic medicines, and nutrition products.

10,001+

Employees

Abbott Park

Headquarters

Reviews

3.4

10 reviews

Work Life Balance

2.5

Compensation

4.0

Culture

2.8

Career

3.2

Management

2.5

45%

Recommend to a Friend

Pros

Good benefits and compensation

Supportive management/teams

Good company reputation and mission

Cons

Poor management and communication

Stressful work environment

Limited career advancement/favoritism

Salary Ranges

1,330 data points

Mid/L4

Senior/L5

Intern

Mid/L4 · Project Manager

215 reports

$136,922

total / year

Base

$117,670

Stock

-

Bonus

$11,503

$94,554

$201,278

Interview Experience

3 interviews

Difficulty

2.7

/ 5

Duration

14-28 weeks

Offer Rate

67%

Experience

Positive 67%

Neutral 33%

Negative 0%

Interview Process

1

Application Review

2

Recruiter Screen

3

Phone Screen

4

Hiring Manager Interview

5

In-person/Final Interview

6

Offer

Common Questions

Technical Knowledge

Behavioral/STAR

Past Experience

Culture Fit