Clinical Research Coordinator

Why This Role Matters
The Regulatory Affairs Medical Expert provides critical scientific and regulatory support for drug development and marketing authorization processes. This role ensures that clinical, preclinical, and technical data are prepared and submitted accurately to regulatory authorities in India, the U.S., EU, and other targeted regions. By guiding regulatory strategies, reviewing dossiers, and supporting interactions with health authorities and sponsors, the role contributes directly to the successful approval and launch of new medicinal products, diagnostics, and devices.

Job Description
The Regulatory Affairs Medical Expert is responsible for defining regulatory strategies, preparing, reviewing, and submitting regulatory dossiers, and liaising with internal teams, sponsors, and health authorities. The role involves ensuring compliance with international regulatory requirements, supporting interdepartmental projects, and maintaining archival systems for all submissions and regulatory guidance. This position requires extensive knowledge of drug development, regulatory frameworks, and scientific evaluation to facilitate approvals and safe market entry of new products.

Key Features Of The Role
• Define regulatory strategies for submission of clinical trial applications
• Develop regulatory approaches for approval and marketing trial applications in India, the U.S., EU, and other targeted regions
• Prepare, review, and submit regulatory documents and dossiers containing technical, preclinical, and clinical data in agency-required formats
• Respond to questions and inquiries from health authorities in a timely and accurate manner
• Support QA audit plans and quality systems management plans
• Prepare and review clinical amendments, safety reports, and data for regulatory approval processes
• Provide regulatory support to interdepartmental project teams and scientific staff
• Liaise with sponsors during preparation of initial regulatory dossiers
• Interact with health authorities through telephone contacts, teleconferences, meetings, and submissions
• Collaborate with internal scientists on scientific and regulatory issues impacting drug development
• Maintain archival systems for all regulatory submissions, contact logs, guidance documents, regulations, and SOPs

Responsibilities
• Develop and implement regulatory strategies for clinical trial and marketing authorization submissions
• Ensure all regulatory submissions comply with local and international guidelines and regulations
• Prepare and review dossiers, including integrated efficacy and safety analyses (ISE and ISS)
• Support generation of integrated databases, pooled analyses, and regulatory reporting documents
• Respond to regulatory authority queries regarding technical, preclinical, and clinical data
• Ensure proper maintenance of regulatory documentation, guidance documents, and SOPs
• Participate in interdepartmental project teams to provide regulatory expertise and guidance
• Support QA audits and quality system management for regulatory processes
• Facilitate communication and alignment between sponsors, internal scientists, and health authorities

Required Qualifications

Educational Requirements
• Bachelor’s or advanced degree (MD, Ph.D., Pharm.D.) in scientific, life sciences, or related field

Experience And Skills
• Minimum of 5 years of experience in regulatory affairs, with at least 8 years in drug development
• Strong knowledge of international regulations and guidelines governing pharmaceutical development
• Experience working with regulatory authorities in India, U.S., EU, or other regions
• Expertise in preparation and review of regulatory dossiers, safety reports, and integrated analyses
• Excellent communication and interpersonal skills to liaise with sponsors, health authorities, and internal teams
• Strong organizational, analytical, and problem-solving skills

Salary Insights
• Competitive compensation aligned with experience and industry standards
• Performance-based incentives and opportunities for professional development
• Exposure to global regulatory processes, drug development, and cross-functional projects

Company Overview
The organization is a global pharmaceutical and biotechnology company focused on delivering innovative therapies and diagnostics worldwide. It emphasizes regulatory compliance, scientific rigor, and collaborative teamwork to bring new medicines to patients. Employees are empowered to contribute to drug development strategies, regulatory submissions, and high-impact projects in a dynamic, international environment.

FAQs
Q: What types of submissions will I work on?
A: Clinical trial applications, marketing authorization applications, regulatory dossiers, safety reports, and integrated analyses for regulatory submissions in India, the U.S., EU, and other regions.

Q: Will I interact with external agencies?
A: Yes, the role requires communication with health authorities, sponsors, and international regulatory agencies.

Q: Is prior regulatory experience required?
A: Yes, candidates should have at least 5 years of regulatory affairs experience with 8 or more years in drug development.

Q: Does this role involve QA and documentation management?
A: Yes, the role supports QA audits, quality systems management, and maintains archival systems for all regulatory submissions and guidance documents.

Application Tips
• Highlight experience in regulatory affairs, dossier preparation, and drug development
• Emphasize knowledge of international regulatory guidelines (India, U.S., EU)
• Showcase experience in clinical, preclinical, and technical data review and submission
• Demonstrate ability to liaise with sponsors, internal teams, and health authorities
• Include examples of successful regulatory submissions and approvals