Principal Regulatory Affairs Assistant
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Bangalore, India | Fully Onsite
Job Type: Full-Time | Onsite
Work Schedule: Standard (Mon–Fri)
Experience: Typically 1+ Years (Regulatory Affairs / Clinical Research)
Qualification: Bachelor’s or Master’s Degree in Life Sciences or Related Discipline
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Assistant to support regulatory documentation and submission activities within clinical research projects.
The role involves preparing and coordinating regulatory submissions, managing project documentation, and ensuring compliance with regulatory guidelines such as EUCTR. The position requires close collaboration with internal teams and external clients to track project progress, maintain documentation, and support regulatory processes.
This role plays an important part in ensuring timely and compliant regulatory submissions, supporting clinical trial approvals and project execution.
Key Responsibilities
1. Regulatory Documentation & Submissions
Support preparation of regulatory documents and submissions under EUCTR guidance.
Ensure documentation meets regulatory requirements and standards.
Assist in maintaining submission-ready documentation.
2. Project Coordination & Management
Coordinate and manage client deliverables related to regulatory activities.
Track project timelines, milestones, and deliverables.
Provide regular status updates to stakeholders.
Ensure alignment with project goals, timelines, and quality expectations.
3. Client Communication & Collaboration
Liaise with internal teams and external clients.
Support communication related to project tracking and updates.
Collaborate with cross-functional teams to ensure smooth project execution.
Engage with stakeholders to resolve issues and remove project barriers.
4. Compliance & Regulatory Knowledge
Maintain knowledge of SOPs, client-specific guidelines, and regulatory requirements.
Ensure adherence to regulatory standards and internal processes.
Support compliance-related activities across projects.
5. Reporting & Documentation Support
Provide project-specific documentation and coordination support.
Assist in preparing reports for management and clients.
Maintain accurate records of project activities and deliverables.
6. Bidding & Proposal Support
Support preparation of bids and proposals.
Generate, track, and analyze data related to proposals and contracts.
Assist in contract modifications and bid defense preparation.
Required Skills
Regulatory Affairs Knowledge
Basic understanding of regulatory submission processes.
Familiarity with EUCTR guidelines and clinical trial regulations.
Knowledge of SOPs and regulatory documentation standards.
Organizational & Project Management Skills
Strong organizational and time management abilities.
Ability to manage multiple tasks and deadlines.
Attention to detail in documentation and tracking activities.
Communication & Interpersonal Skills
Good written and verbal communication skills.
Ability to coordinate with internal and external stakeholders.
Strong interpersonal and collaboration skills.
Analytical & Problem-Solving Skills
Ability to evaluate project requirements and timelines.
Strong problem-solving and decision-making skills.
Capability to identify and resolve project issues.
Technical & Administrative Skills
Proficiency in documentation and reporting tools.
Ability to track and manage project data.
Basic understanding of clinical research systems and workflows.
Preferred Qualifications
Experience in pharmaceutical or CRO clinical research environment.
Exposure to regulatory submissions and compliance processes.
Familiarity with project coordination and documentation management.
Key Competencies
Regulatory documentation and submission support
Project coordination and tracking
Client communication and collaboration
Regulatory compliance and SOP adherence
Reporting and documentation management
Proposal and bid support
Attention to detail and organization
About the Company
Thermo Fisher Scientific is a global leader in scientific services and technologies, supporting research, drug development, and healthcare innovation worldwide.
Through its clinical research division, PPD Clinical Research Services, the organization provides end-to-end clinical trial services including clinical operations, data management, regulatory affairs, and medical writing.
Operating in more than 100 countries with over 100,000 employees globally, the company partners with pharmaceutical and biotechnology organizations to accelerate the development of innovative therapies and deliver life-changing treatments to patients around the world.
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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China | Quarry Bay |Liaoning :
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Tallinn |Hà Nội :
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Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
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Kyiv |Lima Region :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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