Senior Regulatory Affairs Manager

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/A

In 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