Regulatory Affairs Specialist at Thermo Fisher Scientific
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to join their dynamic team. This role plays a critical part in ensuring that clinical research and product development efforts comply with regulatory requirements, contributing to the development of life-saving therapies. If you are passionate about regulatory compliance and scientific innovation, this position offers a rewarding opportunity to be at the forefront of the life sciences industry. Regulatory Affairs Specialist at Thermo Fisher Scientific
Job Overview:
| Position | Regulatory Affairs Specialist |
|---|---|
| Location | Remote, India (Hybrid) |
| Experience | 2+ Years |
| Salary | Not Disclosed |
| Education | B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences |
| Job Type | Full-time |
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you’ll be part of a global team dedicated to driving scientific innovation that impacts lives. This role is ideal for professionals looking to work in a flexible, collaborative environment where regulatory expertise supports breakthrough therapies and healthcare solutions. Regulatory Affairs Specialist at Thermo Fisher Scientific
Key Responsibilities
- Regulatory Documentation & Submissions: Assist in preparing and submitting regulatory documents under the guidance of senior team members.
- Project Management: Coordinate and manage client deliverables to ensure they meet regulatory compliance. Track project plans and provide regular updates to both internal and external stakeholders.
- Budgeting & Forecasting: Support the budgeting and forecasting activities for regulatory projects, ensuring resources are allocated efficiently.
- Client Liaison: Maintain strong relationships with clients, understanding their needs and helping them meet timelines, quality, and delivery goals.
- Regulatory Knowledge: Stay up-to-date on Standard Operating Procedures (SOPs), ICH guidelines, and global regulatory frameworks to ensure compliance throughout the project lifecycle.
- Team Collaboration: Work closely with project team members to resolve any barriers, ensuring smooth project execution.
Regulatory Affairs Specialist at Thermo Fisher Scientific
Requirements
Education:
- Bachelor’s Degree or equivalent qualification in pharmaceutical sciences, life sciences, or a related field.
Experience:
- 2+ years of relevant experience in regulatory affairs or clinical research services.
Skills & Abilities:
- Communication: Strong written and verbal communication skills in English (and local languages if applicable).
- Attention to Detail: High proficiency in editorial/proofreading and quality control.
- Team Collaboration: Excellent interpersonal skills to work within a team environment.
- Technical Proficiency: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Organization & Planning: Exceptional time management and planning skills, with the ability to juggle multiple projects.
- Negotiation Skills: Ability to assess sponsor needs and deliver appropriate regulatory solutions.
- Regulatory Knowledge: Understanding of global and national regulatory frameworks, including clinical trial authorization, licensing, and lifecycle management.
- Medical Terminology: Basic knowledge of medical terminology, statistical concepts, and relevant guidelines.
Regulatory Affairs Specialist at Thermo Fisher Scientific
Work Schedule
- Monday to Friday (Standard Work Hours).
- Hybrid Remote role, with the flexibility to work from the office as needed.
Regulatory Affairs Specialist at Thermo Fisher Scientific
How to Apply
Apply online to join Thermo Fisher Scientific as a Regulatory Affairs Specialist and help advance regulatory strategies that contribute to life-changing medical innovations.
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