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 new medicinal products, and diagnostics and devices.
Job Responsibilities
Define regulatory strategies for
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- Submission of clinical trial applications
- Approval and marketing trial applications in targeted regions (India, U.S, EU)
Prepare and review
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- 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
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- 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
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- 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.
- Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience in working with international regulatory agencies.
