Regulatory Writer – Clinical & Safety | Novartis (Mumbai/Hyderabad)
Job Summary:
Novartis is seeking a skilled Regulatory Writer to lead and support the creation of high-quality clinical and safety documents such as CSRs, DSURs, and RMPs. This full-time role, based in Mumbai or Hyderabad, requires experience in regulatory writing and offers the opportunity to collaborate in cross-functional teams including Clinical Trial Teams (CTTs) and Safety Management Teams (SMTs). If you have a passion for compliance, quality documentation, and regulatory excellence, this is your chance to contribute to a global leader in innovative medicines.
Key Responsibilities:
Author and review clinical and safety regulatory documents including CSRs, DSURs, and RMPs
Serve as lead for outsourced narrative projects and support other outsourced activities
Actively participate in Clinical Trial Teams and Safety Management Teams
Plan data analyses and presentations used in clinical reports
Act as a documentation consultant to ensure adherence to internal and external regulatory standards
Serve as Program Writer for consistency across multiple documents in assigned programs
Coordinate with publishing teams for timely delivery of submission-ready documents
Support Medical Writing systems and process improvements within Regulatory Writing Services (RWS)
Maintain compliance with audit, SOP, and training requirements
Required Skills & Qualifications:
3–5 years of medical writing experience, or 1–3 years with MBBS/PhD
Strong understanding of global regulatory environments and approval processes
Proficiency in authoring documents for drug safety and clinical trials
Excellent written and verbal communication skills
Knowledge of biostatistics principles and ability to interpret clinical data
Experience working in matrix teams across global environments
Strong organizational and problem-solving abilities
Familiarity with submission processes for drug registration
Perks & Benefits:
Competitive salary with performance-linked incentives
Full-time, regular employment with stable career growth
Hybrid work flexibility at Mumbai or Hyderabad location
Access to Novartis training and development resources
Inclusion in global, cross-functional projects
Benefits and rewards outlined in the Novartis Life Handbook
Company Description:
Novartis Healthcare Pvt. Ltd. is a global pharmaceutical leader dedicated to transforming the treatment landscape with cutting-edge therapies. With operations across India and a mission to reimagine medicine, Novartis empowers employees to drive innovation in regulatory, clinical, and drug development services.
Work Mode:
Hybrid – Mumbai or Hyderabad
Call-to-Action:
Ready to deliver impactful regulatory documents that support drug approval and patient safety worldwide? Apply now for the Regulatory Writer role at Novartis India and shape the future of healthcare through precise and compliant scientific communication.
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