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)
📅 Last Date to Apply: April 16, 2025 (Only 4 Hours Left!)
📌 Job ID: 251925
Job Description:
- Prepare, compile, and review CMC (Chemistry, Manufacturing, Controls) & regulatory documents for global submissions.
- Create/revise raw material & packaging specifications.
- Coordinate with cross-functional teams for change control, OOS, OOT evaluations.
- Support financial data management, business plan files, supplier data, and PO creation.
- Assist in global labeling documents, stability data evaluation, and dissolution profile reports.
- Conduct literature surveys for APIs, excipients, and drug products.
- Ensure compliance with regulatory guidelines (ICH, GMP, GCP).
Qualifications:
- Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
- 1-2 years in regulatory affairs, CMC documentation, or quality assurance.
- Strong knowledge of FDA/EMA/WHO guidelines.
2. Regulatory Operations Assistant II (Hybrid – Pune)
📅 Last Date to Apply: April 19, 2025 (3 Days Left)
📌 Job ID: 251404
Job Description:
- Similar responsibilities as Regulatory Operations Associate I, with additional oversight.
- Lead specification setting, lab quality control, and CSV (Computerized System Validation).
- Manage import license coordination, investigation reports, and regulatory compliance.
Qualifications:
- 2-3 years in pharma regulatory operations, CMC, or quality compliance.
- Experience in eCTD submissions, change control, and regulatory audits.
3. Sr. Site Selection Specialist (Remote – Mumbai)
📅 Last Date to Apply: May 31, 2025
📌 Job ID: 251922
Job Description:
- Lead feasibility assessments & site identification for global clinical trials.
- Maintain site ID tools, CDA review, and electronic surveys.
- Develop scoring tools, risk-based monitoring dashboards.
- Analyze site performance metrics & investigator databases.
- Train new team members on site selection processes.
Qualifications:
- 4-5 years in clinical research, with 1+ year in site feasibility.
- Knowledge of ICH-GCP, CTMS, and clinical trial protocols.
- Strong 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
