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Syneos Health Hiring for Central Monitoring & Regulatory Affairs

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Syneos Health is hiring for multiple roles in India, including Central Monitor II / Senior Central Monitor and Regulatory Affairs Associate positions.

These roles are ideal for candidates with experience in clinical research, centralized monitoring, regulatory affairs, and drug development processes. With opportunities across Hyderabad, Gurugram, and Mumbai, this hiring drive offers strong career growth in the pharmaceutical and clinical research domain.


Open Positions

1. Central Monitor II / Senior Central Monitor

๐Ÿ“ Location: Hyderabad / Gurugram (Office-based)
๐Ÿงช Experience Required:

  • 2+ years (Central Monitor II)
  • 3+ years (Senior Central Monitor)

Key Responsibilities

  • Perform centralized monitoring and risk-based data review
  • Analyze patient data using dashboards and visualization tools
  • Identify protocol deviations, safety issues, and data discrepancies
  • Work with EDC, CTMS, and clinical trial systems
  • Raise queries and collaborate with CRAs and project teams
  • Ensure compliance with ICH-GCP guidelines
  • Track study progress and maintain monitoring documentation

2. Regulatory Affairs Associate

๐Ÿ“ Location: Mumbai (Hybrid)
๐Ÿงช Experience Required: 1โ€“3 years (India Market)

Key Responsibilities

  • Manage drug registration dossiers and submissions
  • Work on SUGAM portal for regulatory approvals
  • Handle renewals, variations, and import licenses
  • Maintain regulatory databases and documentation
  • Support labeling, artwork, and lifecycle updates
  • Coordinate with stakeholders and regulatory authorities

Eligibility Criteria

  • Bachelorโ€™s degree in Pharmacy / Life Sciences / related field
  • Experience in:
    • Clinical monitoring or regulatory affairs
    • Drug development or regulatory submissions
  • Knowledge of:
    • ICH-GCP guidelines
    • India regulatory processes (for RA role)
  • Strong analytical, documentation, and communication skills

Required Skills

  • Clinical data analysis and interpretation
  • Hands-on experience with:
    • EDC / CTMS / Medidata Rave
    • Data visualization tools (e.g., Spotfire)
  • MS Excel (advanced functions, pivot tables)
  • Regulatory documentation and dossier preparation
  • SUGAM portal expertise (for RA role)

Salary (Estimated)

  • Central Monitor Roles: โ‚น6 LPA โ€“ โ‚น14 LPA
  • Regulatory Affairs Associate: โ‚น4 LPA โ€“ โ‚น9 LPA

Why Join Syneos Health?

  • Work on global clinical trials and drug development programs
  • Exposure to advanced risk-based monitoring and regulatory frameworks
  • Career progression in clinical research and regulatory affairs
  • Collaborative and innovation-driven work environment
  • Opportunity to work with leading pharmaceutical clients

Job Locations

  • Hyderabad (Office-based)
  • Gurugram (Office-based)
  • Mumbai (Hybrid)

How to Apply

Application Link For Central Monitor II/Sr Central Monitor (Hyderabad / Gurugram) Office based)

Application Link For Regulatory Affairs Associate (Mumbai/ Hybrid) India Mkt

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