ApplyBlast uses AI to match you with the right jobs, tailor your resume and cover letter, and apply automatically so you can land your dream job faster.

Features

Auto Apply Resume Optimizer Cover Letter Optimizer Interview Prep

Company

Social Media

Need Help?

team@applyblast.com

Regulatory Operations Expert at Fortrea - ApplyBlast

Regulatory Operations Expert

Fortrea

3 months ago

3.5 on Glassdoor

Mumbai, India

Hybrid

Full Time

Senior

0 applicants

View Job Listing

Apply to 100+ jobs

About this role

A Scientific Writer serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle-ready CMC documentation. The role ensures scientific consistency and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing by aligning content with Quality-by-Design principles. This position acts as a key interface between science, manufacturing, quality, and regulatory affairs to support global regulatory submissions.

Responsibilities

Develop high-quality CMC documentation for pharmaceutical raw materials and processes
Translate complex analytical and manufacturing data into scientifically rigorous justifications
Ensure scientific content aligns with Quality-by-Design principles and control strategies
Support regulatory submissions and health authority interactions with defensible rationales
Act as a scientific interface between MSAT, Manufacturing, Quality, and Regulatory Affairs

Skills

Qualifications

Bachelor's in Pharmacy or related scienceMSc or PhD in Chemistry or Pharmaceutical SciencesDiploma or Certification in Regulatory Affairs

About Fortrea

fortrea.com

Headquarters

Lake Park, North Carolina, United States

Company Size

10001+ employees

View Profile

Fortrea, a leading CRO, advancing clinical trials through patient-focused clinical solutions that accelerate clinical development, drive trial success, and bring innovative therapies to those who need them most.