Work from Home Regulatory Affairs Specialist Hiring at Thermo Fisher Scientific

Remote Regulatory Affairs Specialist Hiring at Thermo Fisher Scientific

Job Title: Senior Regulatory Affairs Specialist (FLEX)

Location: Remote, India

Job Type: Full-time

Category: Clinical Research

Job ID: R-01291764

Thermo Fisher Scientific is currently hiring a Senior Regulatory Affairs Specialist to join its dynamic team. This full-time remote position offers the opportunity to work at the forefront of clinical research, contributing to critical advancements in healthcare and scientific innovation. Join a respected global contract research organization (CRO) that powers the widely recognised PPD® clinical research portfolio.

Why Thermo Fisher Scientific?

At Thermo Fisher Scientific, we pride ourselves on delivering meaningful work that has a positive impact on a global scale. From developing drugs to combat the world’s toughest health challenges to executing global clinical trials, we strive to make the world healthier, cleaner, and safer.

By joining our Regulatory Affairs Department, you will help provide comprehensive regulatory advice and carry out projects that elevate clinical research efforts globally.

Key Responsibilities:

• Support the preparation of documentation and submissions under EUCTR guidance to ensure full regulatory compliance.
• Liaise with internal and external clients to provide updates on project status and plans.
• Manage client deliverables, ensuring adherence to timelines, quality, and regulatory requirements.
• Evaluate client needs in line with overall project objectives to deliver balanced, actionable recommendations.
• Coordinate with project teams and functional units to support project execution and resolution of challenges.
• Assist in the preparation of project-specific reports, proposals, and bid support documents.
• Utilise knowledge of global regulatory guidelines, SOPs, and client-specific directives during project execution.
• Provide labelling support and maintenance to ensure precise compliance.

Qualifications & Experience Required:

• Bachelor’s degree or equivalent relevant academic qualification (formal vocational training may also be considered).
• 2–3 years of relevant experience in regulatory affairs or a similar role.
• Solid understanding of clinical trial authorisation processes, regulatory procedures, and lifecycle management practices (global, regional, or national).
• Strong English communication skills (written and oral). Knowledge of local languages, where applicable, is advantageous.
• Proficiency in using Microsoft Word, Excel, PowerPoint, and the capacity to learn new technologies.
• Competent organisational, analytical, and time-management skills.
• Basic understanding of statistical concepts and medical terminology.

What We Offer:

At Thermo Fisher Scientific, we nurture growth and professional development through award-winning learning programs. Employees are offered the flexibility to achieve work-life balance while benefiting from competitive salaries and wellness-centric perks.

Joining a family of 100,000+ professionals, you will be part of an environment that fosters collaboration, innovation, and meaningful impact, centred around our shared core values—Integrity, Intensity, Innovation, and Involvement.

Whether you’re looking to advance your career with cutting-edge technological resources or want to immerse yourself in a collaborative global network, Thermo Fisher Scientific provides unparalleled opportunities.

How to Apply

Take the next step in your career by applying for the Senior Regulatory Affairs Specialist position today. Click here to apply.

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