Location : Remote Experience : 5+ years Employment Type : Contractual Role We are seeking an experienced Backend Developer with a strong background in Python and FastAPI. You will be responsible for designing, developing, and maintaining scalable backend systems, APIs, and server-side logic. The ideal candidate should have hands-on expertise in backend development, database optimization, and cloud platforms. Responsibilities Develop and maintain backend services using Python FastAPI Design and implement RESTful APIs and integrate third-party services Work with MySQL databases , design schemas, and optimize queries Ensure code quality, performance, and security through best practices Collaborate with cross-functional teams (DevOps, Product, UI/UX) to deliver high-quality solutions Debug, troubleshoot, and resolve backend production issues Write clean, maintainable, and well-documented code Required Skills & Qualifications 5+ years of experience in Python backend development Strong expertise in FastAPI Solid understanding of RESTful APIs, GraphQL, and microservices architecture Proficiency with database design, optimization, and ORMs Hands-on knowledge of Azure or other cloud platforms Familiarity with CI/CD pipelines, DevOps practices, and Agile methodologies Excellent problem-solving skills and attention to detail
Position: Computer System Validation (CSV) Consultant Experience: 3–5 years Department: Quality Assurance / Compliance Reporting To: QA Head Role Summary We’re looking for a skilled CSV Specialist to support validation and compliance of computerized systems in a regulated (GxP) environment. The role involves managing complete CSV lifecycle deliverables, ensuring alignment with GAMP 5, 21 CFR Part 11, Annex 11, and ICH guidelines. Prior experience with pharmacovigilance (PV) systems will be an added advantage. Key Responsibilities 1. System Validation & Documentation Prepare, review, and maintain all CSV deliverables — including Validation Plans, URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports . Ensure all validation follows the GAMP 5 lifecycle approach. Conduct periodic reviews, revalidation, and manage change control, CAPA, and deviation records. 2. Pharmacovigilance / Regulatory Systems Support validation of safety databases, signal detection tools, or regulatory submission systems. Maintain validated status of PV tools as per global regulatory expectations. 3. Compliance & Audit Readiness Ensure ongoing adherence to GxP, 21 CFR Part 11, Annex 11, and data integrity standards. Provide validation documentation and evidence during audits or inspections. Support system remediation and continuous compliance improvement activities. 4. Cross-Functional Collaboration Partner with QA, IT, Business, and Vendors to deliver validation milestones on time. Offer training and guidance on CSV practices and documentation standards. Monitor timelines and ensure deliverables meet project and quality requirements. Qualifications & Competencies Bachelor’s or Master’s in Life Sciences, Computer Science, Pharmacy, or related field. 3–5 years of direct experience in CSV within a GxP-regulated setting. Proficient with GAMP 5, 21 CFR Part 11, Annex 11, FDA/EMA, and ICH guidelines. Strong understanding of risk-based validation and SDLC (Agile/Waterfall). Experience with Pharmacovigilance systems preferred. Excellent documentation, analytical, and communication skills.
Job Title: Regulatory Affairs Manager Location: Remote Type: Full-time Experience: 7+ About the Role We are seeking an experienced Regulatory Affairs Manager to lead and oversee regional regulatory activities across global markets. This role requires strong leadership, strategic oversight, and hands-on expertise in regulatory submissions and health authority interactions. The ideal candidate will act as the primary interface between the sponsor and regulatory teams, ensuring compliance, efficiency, and excellence in all submission processes. Key Responsibilities Serve as the overall project lead and primary liaison with the sponsor. Provide strategic oversight of DSUR submissions , ensuring timely delivery and quality compliance. Manage communication and submissions with global Health Authorities (MOH, MFDS, TFDA, and others). Monitor and interpret regional regulatory updates to ensure continued compliance with evolving standards. Maintain a comprehensive regulatory intelligence repository for internal and client reference. Validate and confirm submission routes, formats, and requirements for each country or region. Qualifications & Requirements Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Regulatory Affairs . 7+ years of experience in regulatory affairs, preferably within pharmaceuticals, biotech, or clinical research domains. Proven experience handling global regulatory submissions and coordinating with multiple health authorities. Strong understanding of ICH, FDA, EMA, and regional regulatory frameworks . Excellent communication, documentation, and stakeholder management skills. Ability to lead cross-functional teams and manage multiple projects simultaneously.