Are you looking for a rewarding career as a Regulatory Writer? Novartis is hiring experienced Regulatory Writers for their Mumbai and Hyderabad offices. If you have a background in medical writing, clinical research, and regulatory compliance, this could be your next big opportunity!
Job Details
- Position: Regulatory Writer
- Job Requisition ID: REQ-10048706
- Locations: Mumbai (Office), Hyderabad (Office)
- Employment Type: Full-time
- Posted: Recently
About Novartis
Novartis is a global healthcare leader focused on innovative medicines, eye care, and generic pharmaceuticals. With a strong commitment to improving patient outcomes, Novartis operates in over 155 countries and is known for its cutting-edge research and regulatory expertise.
Job Description
Key Responsibilities
As a Regulatory Writer at Novartis, you will:
- Author and review high-quality clinical and safety documents, including:
- Non-registration Clinical Study Reports (CSR)
- Development Safety Update Reports (DSUR)
- 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 with internal standards and regulatory guidelines (FDA, EMA, etc.).
- Act as a documentation consultant to cross-functional teams.
- Support process improvements within Regulatory Writing Services (RWS).
- Maintain audit, SOP, and training compliance.
Skills & Qualifications
Minimum Requirements:
- 3-5 years of medical writing experience (or 1-3 years with MBBS/PhD).
- Strong knowledge of global regulatory processes (submissions, safety reporting).
- Excellent communication & presentation skills.
- Understanding of biostatistics and clinical research.
- Ability to manage multiple projects in a matrix environment.
Preferred Skills:
- Experience in regulatory submissions.
- Cross-functional collaboration in a global, multicultural setting.
- Strong problem-solving and analytical abilities.
Why Join Novartis?
✅ Work with a global leader in pharmaceuticals
✅ Opportunities for career growth & skill development
✅ Innovative & collaborative work environment
✅ Competitive salary & benefits
