The role includes conducting global regulatory market research to identify and understand regulatory requirements, guidelines, and compliance standards across different countries. The candidate will be responsible for monitoring international import and export regulations, ensuring compliance with applicable trade requirements, and managing related regulatory documentation. The role also involves handling deviation management, conducting risk assessments, coordinating CAPA (Corrective and Preventive Actions), identifying compliance gaps, and supporting corrective measures. Additionally, the candidate will monitor changes in global regulatory requirements, coordinate with internal and external stakeholders, maintain compliance records, and ensure regulatory requirements are followed across business operations.
Qualifications:
• Bachelor's or Master's degree in Pharmacy, Life Sciences,
Biotechnology, or a related field.
• Prior experience in Regulatory Affairs or Regulatory Compliance.
• Knowledge of global regulatory requirements and international market regulations.
• Understanding of import and export regulations and compliance procedures.
• Familiarity with deviation management, risk assessment, and CAPA processes.
• Knowledge of Quality Management Systems (QMS) and regulatory documentation.
• Ability to conduct regulatory research and interpret international guidelines.
• Valuable communication, analytical, and coordination skills.
• Proficiency in MS Office. Location Preference: Candidates based in Delhi NCR are preferred.
📌 Regulatory Affairs Specialist (New Delhi)
🏢 Intrinseque Health
📍 New Delhi
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