Clinical Research Coordinator

QED Pharmaceutical Services; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

QED Pharmaceutical Services is seeking a regulatory affairs professional to define regulatory strategies, manage submissions and liaise with health authorities across India, the U.S. and EU.

You will prepare dossiers and ensure compliance throughout product development and approval processes. The ideal candidate has a life sciences degree and at least 5 years in regulatory affairs with 8+ years in drug development, deep knowledge of global regulations, and experience working with international

Qualifications

• Bachelor's or advanced degree in scientific/life sciences or related field.
• Minimum 5 years experience in regulatory affairs with at least 8+ years of drug development experience.
• Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience in working with international regulatory agencies.

Responsibilities

• Defines regulatory strategies for clinical development and regulatory submissions.
• Submission of clinical trial applications.
• Approval and marketing trial applications in targeted regions (India, U.S, EU).
• Prepare and review regulatory documents and dossiers containing technical, preclinical and clinical data in suitable formats.
• Responses to questions and inquiries from health authorities.
• QA audit plans and 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 and health authorities.

Skills

Regulatory affairs

Education

MD/PhD/PharmD or MSc in life sciences

Job description

Job Responsibilities

• Defines 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.


• Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience in working with international regulatory agencies.