Regulatory Writer

Key Responsibilities: Author and review high-quality clinical and safety documents, including Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP). Lead outsourced narrative projects and coordinate regulatory writing activities. Serve as a core member of Clinical Trial Teams (CTT) and Safety Management Teams (SMT). Ensure compliance of documentation with internal standards and external regulatory guidelines. Act as a Program Writer to maintain consistency across documents and manage medical writing resources. Collaborate with publishing teams for timely document submission. Contribute to process improvements within Regulatory Writing Services (RWS). Maintain audit, SOP, and training compliance. Skills & Qualifications: 3-5 years of medical writing experience (or 1-3 years with MBBS/PhD). Strong knowledge of global regulatory requirements (FDA, EMA, ICH guidelines). Experience in clinical research, drug safety, and regulatory submissions. Excellent communication, writing, and problem-solving skills. Ability to manage multiple projects in a matrix environment. Familiarity with biostatistics and risk management plans.

Novartis is a global leader in healthcare and pharmaceuticals, committed to innovation and improving patient outcomes. With a strong presence in Mumbai and Hyderabad, Novartis offers a dynamic work environment, career growth opportunities, and competitive benefits.