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Fortrea, a leading global contract research and healthcare solutions company, is hiring Regulatory Operations Assistant II in Pune and Mumbai. This role offers the opportunity to work on regulatory submissions, specifications, labeling projects, and quality documents supporting global markets including the US, EU, Japan, and ROW.
If you have a degree in Pharmacy or Life Sciences with 1–2 years of regulatory affairs, quality assurance, or analytical science experience, this could be your next big step.
Key Responsibilities
- Prepare, compile, and review CMC (Chemistry, Manufacturing & Controls) and regulatory documents for product submissions.
- Create/revise/approve raw material and packaging specifications.
- Collaborate with cross-functional teams for change control evaluations and impact assessments.
- Support business planning, supplier data management, and PO creation.
- Assist in global labeling documents, QC, and stability data evaluations.
- Conduct literature surveys and prepare regulatory documents for APIs, excipients, and drug products.
- Coordinate for import license requirements and document management.
- Perform Computerized System Validation (CSV) and software upgrades.
- Maintain training, compliance, and quality documentation as per regulatory standards.
- Mentor new associates and support onboarding.
Qualifications & Skills
Minimum Requirements:
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- Bachelor’s in Pharmacy or Life Sciences (Master’s/PhD preferred).
- 1–2 years’ experience in Regulatory Affairs, Quality Assurance, Analytical Science, or related field.
- Proficiency in Microsoft Office, Document Management, and Publishing tools.
- Knowledge of drug development life cycle, GxP, and ICH guidelines.
- Strong analytical, organizational, and review skills.
Preferred:
- Certification/Diploma in Regulatory Affairs.
- Familiarity with Regulatory Information Management (RIM) or electronic data management systems.
- MIS knowledge.
Why Join Fortrea?
- Opportunity to work on global submissions and product registrations.
- Exposure to regulatory, quality, and labeling projects.
- Career growth in a leading healthcare and life sciences company.
- Hybrid/office work flexibility.
Application Details
- Job Title: Regulatory Operations Assistant II
- Location: Pune, Mumbai
- Company: Fortrea
- Job Type: Full-time
- Deadline to Apply: September 6, 2025
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