Thermo Fisher Scientific is hiring a Regulatory Affairs Specialist for a full-time, fully onsite position in Bangalore, India. The role involves preparing regulatory documentation and submissions under EUCTR guidance, coordinating client deliverables, tracking project timelines, and supporting regulatory compliance.
Candidates with a bachelor’s or master’s degree and at least 2 years of comparable professional experience can apply for this Regulatory Affairs Specialist job.
Job Details
| Particulars | Details |
|---|---|
| Company | Thermo Fisher Scientific |
| Job Title | Regulatory Affairs Specialist |
| Job Location | Bangalore, India |
| Work Mode | Fully Onsite |
| Employment Type | Full Time |
| Work Schedule | Monday to Friday |
| Experience | 2+ years of comparable experience |
| Qualification | Bachelor’s or Master’s degree, or equivalent relevant formal academic/vocational qualification |
| Job Requisition ID | R-01370062 |
| Official Application | Apply Online |
Position: Regulatory Affairs Specialist
The Regulatory Affairs Specialist will support regulatory documentation and submissions under EUCTR guidance while coordinating project activities, monitoring deliverables, maintaining compliance with applicable guidelines, and assisting with bids and proposals.
Key Responsibilities
- Support the preparation of regulatory documentation and submissions under EUCTR guidance.
- Coordinate and manage client deliverables to support regulatory compliance.
- Track project plans, provide status updates, and liaise with internal and external clients.
- Maintain knowledge of standard operating procedures (SOPs), client SOPs, directives, and current regulatory guidelines.
- Evaluate client requirements against project timelines, quality standards, and delivery expectations.
- Collaborate with project teams, functional units, and management to resolve issues and mitigate delivery barriers.
- Prepare project-specific documentation, coordinate activities, and support management and client reporting.
- Assist with bids and proposals, including generating, tracking, and analysing data for proposal revisions, contract modifications, and bid defences.
Eligibility and Qualifications
Candidates applying for the Thermo Fisher Scientific Regulatory Affairs Specialist vacancy should meet the following requirements:
- Education: Bachelor’s or Master’s degree, or an equivalent relevant formal academic or vocational qualification.
- Experience: At least 2 years of comparable experience providing the knowledge, skills, and abilities required for the position.
Required Skills and Competencies
The job responsibilities indicate the need for capabilities in:
- Regulatory documentation and submission support.
- Understanding of EUCTR guidance and regulatory compliance.
- SOP and regulatory guideline management.
- Project coordination and deliverable tracking.
- Client communication and stakeholder coordination.
- Project reporting and documentation.
- Data generation and analysis for bids, proposals, and contract modifications.
- Issue resolution and project timeline management.
Application Details
