Regulatory Affairs Lead- FSP

Position Overview

• Location Type: Client Dedicated (Remote)
• Job Type: Part time
• Salary: Not specified

A client-dedicated role for a Regulatory Affairs Lead within Thermo Fisher Scientific, supporting clinical trial new indications across various stages of development. This role requires global experience, with EU CTR experience being particularly important. The Reg Affairs Lead will act as the lead over several countries/projects, providing strategic regulatory intelligence and guidance to support product development from preclinical through registration and product optimization. They will also serve as a liaison with internal and external clients, providing strategic and efficient preparation of deliverables that meet regulatory and technical requirements.

Requirements

• Global Regulatory Affairs experience
• EU Clinical Trial Regulation (CTR) experience is highly desirable
• Strong understanding of regulatory requirements (local, regional, and ICH)
• Ability to provide regulatory strategy advice
• Experience with clinical trial submissions
• Excellent communication and interpersonal skills
• Project management skills

Responsibilities

• Provides senior review of regulatory documents and submissions.
• Acts as a subject matter expert in providing regulatory strategy advice.
• Provides up-to-date legislation and guidance to internal and external clients.
• Participates in project management activities to support regulatory services.
• Acts as a liaison with internal and external clients in the provision of marketing services.
• Provides matrix/project leadership, training, and guidance to junior team members.
• Ensures adherence to project budgets, time schedules, and scope of work.

Application Instructions

• Not specified

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Services: Clinical trials conducted in 100+ countries, PPD clinical research portfolio (laboratory, digital, and decentralized clinical trial services).