RESPONSIBILITIES
- Develop high-quality Clinical trial content for Regulatory Intelligence including expert summary generation and cross-country tables.
- In-depth knowledge on clinical trial regulatory including:
- Requirements in all phases of drug development (phase I-IV studies)
- Clinical trial applications and ethics committees
- Regulatory processes and approval times
- Knowledge on clinical trial registries and results disclosed.
- Ability to assess impact of new regulatory requirements.
- Compassionate Use/Expanded Access programs
- Ability to assess and anticipate impact of recent regulatory requirements on clinical trials.
- Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence content related to Clinical trials content.
- Perform quality control checks on contributions from external experts related to Clinical trials content.
- Acts as a Subject Matter Expert (SME)



in regulatory knowledge for Clinical trials.
- Manage workload effectively by understanding the scope of work and deliverables, ensuring timely and accurate outcomes.
- May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
- May conduct and present regulatory training sessions for small groups or individuals within the Regulatory Intelligence team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- In-depth understanding of regulatory requirements and guidelines for Clinical trials, including those from the FDA, EMA, and other international regulatory bodies.
- Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
- Minimum 5 years of relevant experience in Clinical trials

Disclaimer: This job posting has been agg

📌 Snr Reg Affairs officer (Bengaluru)
🏢 Iqvia Biotech
📍 Bengaluru