Provides medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs, dossiers for regulatory submissions for market authorizations of current medicinal products, and diagnostics and devices.

Job Responsibilities

Define regulatory strategies for
Submission of clinical trial applications
Approval and marketing trial applications in targeted regions (India, U.S, EU)

Prepare and review
- Regulatory documents
Dossiers containing technical, pre clinical and clinical data in suitable formats
Responses to questions and inquiries from health authorities
QA audit plans
Quality systems management plans
Clinical amendments and safety reports
Data provided for regulatory approval process

Interact/liaise with
- Sponsors in the preparation of initial regulatory dossiers
Health authorities (telephone contacts,



teleconferences, meetings, submissions)
Incyte scientists on any unique scientific/regulatory issues that impact drug development
Regulatory support to inter departmental project teams
Maintain archival systems for
- All regulatory submissions and contact logs
Regulatory guidance documents, regulations and information
QA, clinical and other SOPs

Qualifications/Experience
Bachelors or advanced degree (MD, Ph.D. or Pharm.D.) in scientific/life sciences or related field.
A minimum of 5 years experience in regulatory affairs with at least 8 or more years of drug development experience.
Solid knowledge of regulations/guidelines governing development of pharmaceuticals; experience in working with international regulatory agencies.

📌 Clinical Research Coordinator Hyderabad (India)
🏢 QED Pharmaceutical Services
📍 India