Thermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $40 billion. The company’s mission is to enable customers to make the world healthier, cleaner, and safer. With operations in over 100 countries, Thermo Fisher Scientific provides innovative solutions in life sciences, diagnostics, and laboratory technologies.
As part of its PPD® clinical research portfolio, Thermo Fisher Scientific delivers cutting-edge contract research organization (CRO) services, supporting drug development and clinical trials worldwide.
Job Description: Regulatory Publishing Specialist
Key Responsibilities
- Prepare and manage electronic regulatory submissions (eCTD and other formats) in compliance with ICH, FDA, and global regulatory requirements.
- Ensure quality control of regulatory documents, including formatting, hyperlinking, and validation checks.
- Collaborate with cross-functional teams to meet submission deadlines and maintain compliance.
- Utilize Microsoft Word, Excel, Adobe Acrobat, and regulatory publishing tools to format and troubleshoot documents.
- Support project-specific processes for sponsors with unique submission requirements.
- Maintain document management systems and ensure adherence to regulatory standards.
Qualifications & Experience
- Bachelor’s degree in a relevant field (Life Sciences, Pharmacy, Regulatory Affairs, etc.).
- 2+ years of experience in regulatory publishing, eCTD submissions, or document management.
- Strong knowledge of FDA, EMA, and ICH guidelines for electronic submissions.
- Proficiency in Microsoft Office, Adobe Acrobat, and regulatory publishing software.
- Excellent attention to detail, organizational skills, and ability to manage multiple projects.
Work Schedule & Benefits
- Full-time, remote position (India-based).
- Competitive salary, annual bonuses, healthcare benefits, and career growth opportunities.
- Inclusive work culture with a focus on innovation, integrity, and professional development.
