bengaluru karnataka regulatory affairs manager Jobs – 47 Open Jobs Today

Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs
Cepheid —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Travel
- Paid time off
Manager Regulatory Affairs - IN
DeepHealth —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Communication skills
Quick apply
RC-REGULATORY COMPLIANCE-Regulatory - BA-Manager
EY —Bengaluru, Karnataka
- Management
- PMP
- Analysis skills
13d
Program Manager, Regulatory Affairs, Maternal Infant Care
GE HEALTHCARE —Bengaluru, Karnataka
- Microsoft Word
- Computer Science
- Word processing
Staff Regulatory Affairs - Bangalore
Beckman Coulter Life Sciences —Bengaluru, Karnataka
- Full-time
- Remote
- Master's degree
- Project management
- AI
- Paid time off
- Work from home
Specialist - Regulatory Affairs - Operations 4A
Genpact India Pvt. Ltd. —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Data analysis skills
- English
- Master's degree
Quick apply
14d
Senior Regulatory Affairs
Saraca Solutions —Bengaluru, Karnataka
- Bachelor's degree
- Travel
- Communication skills
Manager - CMC Regulatory
Elanco —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Travel
Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs
Cepheid —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- Master's degree
- Machine learning
- Paid time off
LEAD - GROUP PUBLIC AFFAIRS
Mahindra & Mahindra Ltd —Bengaluru, Karnataka
- Master's degree
- Bachelor's degree
- Agile
Regulatory Submissions Manager
ICON Plc —Bengaluru, Karnataka
- Full-time
- Bachelor's degree
- Health insurance
Expert Regulatory Project Manager
Merck Group —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- English
- Master's degree
QUALITY & REGULATORY MANAGER
Achira Labs —Bengaluru, Karnataka
- Master's degree
- Bachelor's degree
- Mentoring
Quick apply
8d
Expert-Regulatory Submission Management
Merck KGaA —Bengaluru, Karnataka
- Doctoral degree
- Master's degree
- Communication skills
Analyst - Scientific Communications & Medical Information
AstraZeneca —Bengaluru, Karnataka
- Full-time
- Medicine
- Doctoral degree
- Project management
1d
Forms Completion Specialist / Regulatory Compliance Specialist
Lee Spring Company India Pvt Ltd —Bengaluru, Karnataka
- ₹5,00,000 - ₹7,00,000 a year
- Full-time
- Computer Science
- Bachelor's degree
- Human resources
- Health insurance
- Paid time off
Quick apply
6d
Manager — Public Policy
Growth School —Bengaluru, Karnataka
- Full-time
- AI
- Communication skills
Chemical Compliance Project Manager
Thermo Fisher Scientific —Bengaluru, Karnataka
- Full-time
- PMP
- Master's degree
- Analysis skills
Associate Director - Content Quality Review - Global Content Hub
Lilly —Bengaluru, Karnataka
- Full-time
- Medicine
- Management
- Doctoral degree
Manager - Legal & Compliance
ISKCON Bangalore (Hare Krishna Hill) —Bangalore City, Bengaluru, Karnataka
- ₹40,000 - ₹55,000 a month
- Full-time
- Bachelor's degree
- Organizational skills
- In-person
- Health insurance
Quick apply

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Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs

Cepheid -
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Benefits

Paid time off

Qualifications

Clinical research
Master's degree
Science
Bachelor's degree
Data management
M.Sc
User acceptance testing
Organizational skills
Automotive diagnostics

Full job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Learn about the Danaher Business System which makes everything possible.

The Lead Clinical Data Manager is responsible for ensuring the accuracy, completeness and integrity of data collected during IVD clinical trials. The CDM is responsible for developing the clinical data management plan for pre-market and post-market clinical trials and timely execution of the plans throughout the lifecycle of the study.

This position reports to the Clinical Affairs Manager, Global QRC On-market Sustainment and will be an on-site role in Bengaluru, India.

In this role, you will have the opportunity to:

Develop clinical study data management plans and provide clinical data management support for clinical teams, study projects, and biostatistics, including execution of data management plans across the full study lifecycle.
Develop case report forms (or eCRF), clinical trial data specifications, EDC database specifications, user requirements, edit rules/checks, query logic and data validations.
Define and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.

The essential requirements of the job include:

Bachelor's or master's degree in science or health care area
5+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
Experience with executing database lock, freeze, close-out audits and archival activities for a clinical trial; manage external data transfers by developing data transfer agreements, reconciling electronic data transfers, generating data listings, validating summary tables, and preparing datasets for statistical review and audit readiness.
Demonstrate proficiency with user acceptance testing following database upgrades or migrations, EDC user management across clinical trials, and creation of user guides for EDC training.
Understand data system compliance by following the established guidelines of regulatory authorities.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

Occasional travel up to 25%

It would be a plus if you also possess previous experience in:

Experience in in-vitro diagnostics (IVD), Pathology, and Companion Diagnostics clinical research
Demonstrated ability to explain complex or sensitive information to diverse audiences, including senior leaders; excellent organizational skills and ambition to continuously improve together with the business

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Apply Now

Refine Your Search

regulatory affairs manager jobs in bengaluru karnataka

Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs

Manager Regulatory Affairs - IN

RC-REGULATORY COMPLIANCE-Regulatory - BA-Manager

Program Manager, Regulatory Affairs, Maternal Infant Care

Staff Regulatory Affairs - Bangalore

Specialist - Regulatory Affairs - Operations 4A

Senior Regulatory Affairs

Manager - CMC Regulatory

Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

LEAD - GROUP PUBLIC AFFAIRS

Regulatory Submissions Manager

Expert Regulatory Project Manager

QUALITY & REGULATORY MANAGER

Expert-Regulatory Submission Management

Analyst - Scientific Communications & Medical Information

Forms Completion Specialist / Regulatory Compliance Specialist

Manager — Public Policy

Chemical Compliance Project Manager

Associate Director - Content Quality Review - Global Content Hub

Manager - Legal & Compliance

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