Indegene, a leading technology-driven healthcare solutions provider, is seeking a Regulatory Specialist to join its dynamic team in Bengaluru, Karnataka, India. This is a hybrid, full-time role that offers an exciting opportunity to work at the intersection of healthcare and technology. With over 100 applicants already, this position is highly sought after. If you have a background in regulatory writing and a passion for healthcare innovation, this could be the perfect role for you.
About Indegene
Indegene is a global organization dedicated to enabling healthcare companies to be future-ready. With a focus on innovation, collaboration, and empathy, Indegene offers accelerated growth opportunities for bold and nimble talent. The company operates at the cutting edge of healthcare and technology, providing a unique career experience that celebrates entrepreneurship and leadership.
Job Overview
- Designation: Senior Associate/Lead/Associate Manager – Scientific Writing
- Location: Bengaluru, Hyderabad, Delhi/NCR, Mumbai, Pune
- Experience: 5 to 15 years in clinical and regulatory writing
- Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
- Notice Period: Immediate joiners preferred
Key Responsibilities
As a Regulatory Specialist, you will:
- Develop and review clinical and regulatory documents, including CTD Module 2 and Module 5, clinical study reports (CSRs), protocols, and Investigator Brochures (IBs).
- Lead cross-functional teams to draft scientific and medical content, ensuring alignment with regulatory requirements.
- Manage document workflows, including review, quality control, and finalization under tight deadlines.
- Train and mentor junior writers, fostering a culture of excellence and continuous improvement.
- Stay updated on regulatory guidelines and industry best practices to ensure compliance.
Required Skills
- Expertise in authoring regulatory documents such as Module 2.3, 2.4, 2.5, 2.7, and 5.2.
- Strong understanding of clinical development processes and trial design.
- Excellent communication, time management, and organizational skills.
- Proficiency in MS Word and document management systems.
- Ability to work independently and collaboratively in a fast-paced environment.