Regulatory Operations Assistant I
Fortrea
full-time
Posted on:
Location Type: Hybrid
Location: Pune • 🇮🇳 India
Visit company websiteJob Level
Junior
Tech Stack
Google Cloud Platform
About the role
- Prepare, compile and review product quality (CMC) and other regulatory documents.
- Create/revise/approve raw material and packaging specifications.
- Coordinate and interact with cross-functional teams for evaluation of change control.
- Support Financial Data Management, Business Plan file creation and maintenance.
- Support for creation and update of global labeling documents.
- Perform literature survey and prepare regulatory documents in support of excipients, APIs and/or drug products.
Requirements
- Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters).
- 0-1 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical science / Pharmaceutics / material management and overall drug development and manufacturing process).
- Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
- Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
- Speaking-English and/or other languages as applicable.
Benefits
- Flexible work environment
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentsquality controlraw material specificationspackaging specificationschange controlliterature surveyexcipientsAPIsdrug productspharmaceutical product life cycle
Soft skills
coordinationcommunicationcross-functional teamwork
Certifications
Bachelor’s in PharmacyPhDMasters