Regulatory Intelligence and Operational Excellence Lead

Fresenius Medical CareHebbal, BangalorePosted 10 days ago

Lead or staff
Hybrid
Full time
12 to 18 years

A free account shows the apply link for every role and matches you to the ones that fit your resume.

About the role

Fresenius Medical Care develops kidney care products, services and care, with a global function supporting product quality, safety and regulatory compliance. This role leads regulatory intelligence, knowledge sharing and operational processes for Global Drug Regulatory Affairs.

What you'll do

Monitor global regulatory guidance, inspection trends and competitor approvals
Prepare actionable intelligence briefs and maintain a searchable knowledge base
Coordinate SOP governance, onboarding, training and POA action tracking
Map regulatory workflows and support continuous improvement and root-cause assessment
Maintain operational dashboards and report progress and risks to leadership
Integrate regulatory intelligence into RIMS and GDRA platforms

Skills

Must have

Regulatory intelligence
Regulatory affairs
Regulatory guidance analysis
Sop governance
Training coordination
Continuous improvement
Regulatory knowledge management
Regulatory submissions

Nice to have

Cmc
Labeling
Nonclinical
Shared services

Tools

Sharepoint
Teams
Rims
Citeline
Raps

Who it's for

Education: Bachelor's degree
Degree: pharmacy, life sciences, chemistry, biochemistry
Experience: 12 to 18 years
Languages: english
Domain: healthcare

About Fresenius Medical Care

Fresenius Medical Care has 35 open roles in Bangalore, at Fresenius Medical Care Global Business Services (GBS) Bangalore. See every Fresenius Medical Care role.