Apply Now

Global Regulatory Affairs

Remote • Posted 1 day ago • Updated 1 day ago

Contract W2

5 Months

Remote

$115 - $120/hr

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

Regulatory Affairs
Oncology
FDA
EMA

Summary

Trident Consulting is seeking a " Global Regulatory Affairs Director for one of our client in "Remote". A global leader in business and technology services.

Role: Global Regulatory Affairs Director (Global Regulatory Lead)

Location: Remote (Must be based in the U.S.)
Preferred Time Zone: EST
Employment Type: Contract (40 hrs/week)
Interview: Virtual
Priority: High Priority Immediate Need
Start Date: ASAP (Preferred before Sept. 17 18)
Pay: $120/hr on w2

Position Summary

The Global Regulatory Lead will develop and execute global regulatory strategies, lead regulatory activities for assigned oncology programs, manage global submissions, and represent Regulatory Affairs on cross-functional project teams.

Key Responsibilities

Lead global regulatory strategy and execution for assigned programs.
Represent Regulatory Affairs on Global Project Teams.
Lead the Global Regulatory Sub-Team (GRST).
Manage global regulatory submissions through approval.
Coordinate FDA/EMA regulatory interactions and briefing documents.
Develop regulatory strategies aligned with development plans.
Collaborate with Regulatory Project Management and Submission Management.
Provide matrix leadership across cross-functional teams.

Required Qualifications

Advanced degree (MS, PhD, PharmD, MD, or equivalent).
6+ years of Regulatory Affairs experience.
3+ years of recent Oncology Regulatory experience (Required).
Strong experience with FDA and/or EMA interactions.
Proven experience leading global regulatory strategies.
Excellent matrix leadership, communication, and stakeholder management skills.
Strong written and verbal English communication.

Preferred Keywords

Global Regulatory Affairs
Regulatory Strategy
Oncology
FDA
EMA
IND
NDA
BLA
Global Submissions
Regulatory Project Management
Matrix Leadership
Health Authority Interactions

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10121769
Position Id: BP236
Posted 1 day ago

Contact the job poster

Mahendra Kumar

Recruiter @ Central Business Solutions

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Regulatory Specialist

Remote or Raynham, Massachusetts

•

Today

Kelly Science and Clinical FSP is currently seeking a Regulatory Specialist for a long-term engagement with one of our Global MedTech clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible

Easy Apply

Contract

Regulatory Affairs Specialist

Remote

•

4d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as invent

Easy Apply

Third Party, Contract

$60 - $70

Regulatory Affairs Data Coordinator

Remote or Irvine, California

•

Today

Kelly Science and Clinical FSP is currently seeking an RA Data Coordinator for a long-term engagement in Irvine, CA with one of our Global clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eli

Easy Apply

Contract

Regulatory Manager, Advertising and Promotions

Remote

•

Today

Vega is Staffing a Part time position (20 hours a week) for our direct Pharma Client. Seeking candidates with a strong back ground in Pharma, Regulatory Management and Advertising and Promotions. Minimum Requirements Bachelor's Degree In Scientific or Health Discipline5 years Of pharmaceutical/medical device industry experience and minimum of 5 years as a regulatory affairs reviewer of advertising and promotional materials5+ years with a proven track record of successful internal stakeholder ma

Easy Apply

Contract

Depends on Experience

Search all similar jobs

Remote jobs at Central Business Solutions