Position: Senior Executive – Quality Assurance & Regulatory Affairs Location: Edapally,Kochi | Employment Type: Full-Time | Experience: 3–6 Years Position Overview: We are seeking a highly motivated Senior Executive – Quality Assurance & Regulatory Affairs to establish and manage the Quality and Regulatory systems for pre-clinical stage drug development program. The role will play a key part in supporting compliance for ongoing R&D and pre-clinical studies, laying the foundation for GxP readiness, and managing early regulatory communications. This is a strategic hands-on role for a professional, passionate candidate about building quality and compliance frameworks from the ground up in a fast-paced startup environment. The person will be working closely with cross-functional R&D teams and leadership to shape the quality culture and regulatory strategy and gets a unique opportunity to become key foundational personnel in a mission driven drug development program. Key Responsibilities: · Establish initial QA systems aligned with GLP and other applicable regulatory guidelines for R&D and pre-clinical environments. · Draft, implement, and maintain Standard Operating Procedures (SOPs) , policies, and work instructions across departments. · Support data integrity , documentation review , and record-keeping for lab notebooks, protocols, study reports, etc. · Coordinate internal audits and prepare the organization for external audits and inspections (CROs, vendors, regulators). · Oversee vendor/CRO qualification , quality agreements, and ensure quality oversight of outsourced pre-clinical activities. · Ensure training compliance for scientific and operational staff on quality systems and regulatory requirements. · Maintain awareness and interpret relevant regulatory guidelines (CDSCO, ICH, US FDA, EMA, etc.) applicable to early-stage drug development. · Prepare and manage regulatory documentation (Pre-IND briefing packages, initial regulatory inquiries, ethics submissions). Qualifications & Skills: · Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field . · 3–6 years of experience in QA/RA functions in a pharmaceutical, biotech, or CRO environment, ideally in early development/preclinical phase. · Hands-on experience with GLP practices , regulatory compliance , and SOP development . · Familiarity with regulatory frameworks (ICH, OECD, US FDA IND pathways). · Strong organizational skills and attention to detail with the ability to handle multiple responsibilities in a startup setting. · Effective verbal and written communication skills, especially in regulatory and technical documentation. · Strong understanding of Quality Management Systems (QMS), GMP, GLP compliance Certifications (Preferred but not mandatory) · GLP/GMP/GCP Training Certification · Quality Management System (QMS) Certification · Regulatory Affairs Certification Soft Skills · Excellent attention to detail and strong documentation skills. · Proactive and solution-oriented mindset with ability to manage priorities independently. · Strong interpersonal and communication skills. · Capability to work in dynamic startup environments with cross-functional collaboration. Compensation & Benefits · Health Insurance · Second Saturdays & All Sundays Off · Opportunities for Learning & Career Development: To work with International renowned research institutions and pharma companies · Exposure to cutting-edge R&D projects and regulatory strategy · Collaborative & inclusive work culture that values innovation and accountability How to Apply Send your updated CV and cover letter to careers@luxmatra.com with the subject line: Application – Senior Executive – QA & RA

Position: Senior Executive – Quality Assurance & Regulatory Affairs Location: Edapally,Kochi | Employment Type: Full-Time | Experience: 3–6 Years Position Overview: We are seeking a highly motivated Senior Executive – Quality Assurance & Regulatory Affairs to establish and manage the Quality and Regulatory systems for pre-clinical stage drug development program. The role will play a key part in supporting compliance for ongoing R&D and pre-clinical studies, laying the foundation for GxP readiness, and managing early regulatory communications. This is a strategic hands-on role for a professional, passionate candidate about building quality and compliance frameworks from the ground up in a fast-paced startup environment. The person will be working closely with cross-functional R&D teams and leadership to shape the quality culture and regulatory strategy and gets a unique opportunity to become key foundational personnel in a mission driven drug development program. Key Responsibilities: · Establish initial QA systems aligned with GLP and other applicable regulatory guidelines for R&D and pre-clinical environments. · Draft, implement, and maintain Standard Operating Procedures (SOPs) , policies, and work instructions across departments. · Support data integrity , documentation review , and record-keeping for lab notebooks, protocols, study reports, etc. · Coordinate internal audits and prepare the organization for external audits and inspections (CROs, vendors, regulators). · Oversee vendor/CRO qualification , quality agreements, and ensure quality oversight of outsourced pre-clinical activities. · Ensure training compliance for scientific and operational staff on quality systems and regulatory requirements. · Maintain awareness and interpret relevant regulatory guidelines (CDSCO, ICH, US FDA, EMA, etc.) applicable to early-stage drug development. · Prepare and manage regulatory documentation (Pre-IND briefing packages, initial regulatory inquiries, ethics submissions). Qualifications & Skills: · Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field . · 3–6 years of experience in QA/RA functions in a pharmaceutical, biotech, or CRO environment, ideally in early development/preclinical phase. · Hands-on experience with GLP practices , regulatory compliance , and SOP development . · Familiarity with regulatory frameworks (ICH, OECD, US FDA IND pathways). · Strong organizational skills and attention to detail with the ability to handle multiple responsibilities in a startup setting. · Effective verbal and written communication skills, especially in regulatory and technical documentation. · Strong understanding of Quality Management Systems (QMS), GMP, GLP compliance Certifications (Preferred but not mandatory) · GLP/GMP/GCP Training Certification · Quality Management System (QMS) Certification · Regulatory Affairs Certification Soft Skills · Excellent attention to detail and strong documentation skills. · Proactive and solution-oriented mindset with ability to manage priorities independently. · Strong interpersonal and communication skills. · Capability to work in dynamic startup environments with cross-functional collaboration. Compensation & Benefits · Health Insurance · Second Saturdays & All Sundays Off · Opportunities for Learning & Career Development: To work with International renowned research institutions and pharma companies · Exposure to cutting-edge R&D projects and regulatory strategy · Collaborative & inclusive work culture that values innovation and accountability How to Apply Send your updated CV and cover letter to career@luxmatra.com with the subject line: Application – Senior Executive – QA & RA