Principal Regulatory Affairs Assistant – Bengaluru, Karnataka, India
Location: Bengaluru, Karnataka, India
Job ID: R-01336706
Job Type: Full-Time
Category: Clinical Research / Regulatory Affairs
Work Mode: Fully Onsite
About the Role
Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Assistant to join our Clinical Research and Regulatory Affairs team in Bengaluru. This role offers an excellent opportunity for professionals with 1+ years of experience in regulatory affairs or clinical research to contribute to global regulatory submissions and compliance activities.
In this role, you will support the preparation, tracking, and submission of regulatory documentation, ensuring compliance with EU Clinical Trials Regulations (EUCTR) and client-specific requirements. You will collaborate with cross-functional teams, internal stakeholders, and external clients to maintain timelines, quality, and deliverables for assigned projects.
Key Responsibilities
Prepare and manage regulatory documentation and submissions in compliance with EUCTR guidance.
Coordinate client deliverables to ensure regulatory compliance and timely project execution.
Track project plans, maintain status updates, and communicate progress to internal and external stakeholders.
Apply knowledge of SOPs, client directives, and current regulatory guidelines to support project execution.
Evaluate client requirements relative to project timelines, quality, and deliverables.
Collaborate with project team members, functional units, and management to resolve issues or remove barriers to delivery.
Provide project-specific services, including documentation, coordination, and reporting to management and clients.
Support the preparation of bids, proposals, and contract modifications, including data tracking, analysis, and revisions.
Education & Experience Requirements
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
Minimum 1+ years of experience in regulatory affairs, clinical research, or related domain.
Familiarity with EUCTR, regulatory submission processes, and project documentation is preferred.
Skills & Competencies
Strong organizational skills with the ability to manage multiple projects simultaneously.
Excellent written and verbal communication skills with a strong command of English.
Attention to detail and commitment to quality in regulatory documentation.
Ability to collaborate effectively across internal teams and external clients.
Knowledge of SOPs, client directives, and regulatory requirements.
Analytical and problem-solving skills with a proactive approach to identifying and resolving challenges.
Why Join Thermo Fisher Scientific
Global exposure: Work on regulatory submissions and clinical trials supporting international programs.
Career growth: Opportunities to advance along regulatory affairs and clinical research tracks.
Learning & development: Access mentorship, training, and continuous learning programs.
Impactful work: Contribute to the development and delivery of life-changing therapies.
Thermo Fisher Scientific is a global leader in serving science, with a mission to make the world healthier, cleaner, and safer. Join a collaborative team of professionals dedicated to advancing science and improving patient outcomes.
Thermo Fisher Scientific is an Equal Employment Opportunity Employer.
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