Fortrea, a leading global contract research organization (CRO), is hiring for three critical positions in Pune and Mumbai. If you have experience in regulatory operations, clinical site selection, or feasibility studies, this is an excellent opportunity to advance your career with a reputed organization.
1. Regulatory Operations Associate I (Hybrid – Pune)
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Last Date to Apply: April 16, 2025 (Only 4 Hours Left!)
๐ Job ID: 251925
Job Description:
- Prepare, compile, and reviewย CMC (Chemistry, Manufacturing, Controls) & regulatory documentsย for global submissions.
- Create/reviseย raw material & packaging specifications.
- Coordinate with cross-functional teams forย change control, OOS, OOT evaluations.
- Supportย financial data management, business plan files, supplier data, and PO creation.
- Assist inย global labeling documents, stability data evaluation, and dissolution profile reports.
- Conductย literature surveysย for APIs, excipients, and drug products.
- Ensure compliance withย regulatory guidelines (ICH, GMP, GCP).
Qualifications:
- Bachelorโs/Masterโs inย Pharmacy, Life Sciences, or related field.
- 1-2 years inย regulatory affairs, CMC documentation, or quality assurance.
- Strong knowledge ofย FDA/EMA/WHO guidelines.
2. Regulatory Operations Assistant II (Hybrid – Pune)
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Last Date to Apply: April 19, 2025 (3 Days Left)
๐ Job ID: 251404
Job Description:
- Similar responsibilities asย Regulatory Operations Associate I, with additional oversight.
- Leadย specification setting, lab quality control, and CSV (Computerized System Validation).
- Manageย import license coordination, investigation reports, and regulatory compliance.
Qualifications:
- 2-3 years inย pharma regulatory operations, CMC, or quality compliance.
- Experience inย eCTD submissions, change control, and regulatory audits.
3. Sr. Site Selection Specialist (Remote – Mumbai)
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Last Date to Apply: May 31, 2025
๐ Job ID: 251922
Job Description:
- Leadย feasibility assessments & site identificationย for global clinical trials.
- Maintainย site ID tools, CDA review, and electronic surveys.
- Developย scoring tools, risk-based monitoring dashboards.
- Analyzeย site performance metrics & investigator databases.
- Train new team members onย site selection processes.
Qualifications:
- 4-5 yearsย in clinical research, withย 1+ year in site feasibility.
- Knowledge ofย ICH-GCP, CTMS, and clinical trial protocols.
- Strongย data analysis, Excel, and presentation skills.
About Fortrea
Fortrea is a top-tier CRO providing comprehensive clinical trial solutions to biotech and pharma companies. With a focus on innovation and compliance, Fortrea supports drug development, regulatory submissions, and post-market surveillance globally.
How to Apply?
Application Link For Regulatory Operations Associate I
Application Link For Regulatory Operations Assistant II
Application Link For Sr. Site Selection Specialist