Novartis Careers 2026 | Regulatory Coordinator Hyderabad

Novartis Careers 2026 | Regulatory Coordinator Jobs Hyderabad Novartis Hiring | Regulatory Coordinator Hyderabad Bachelor's / Master's (Pharmacy / Life Sciences / Biotech) Are you searching for regulatory coordinator jobs in Hyderabad, Novartis Regulatory Affairs vacancies, or regulatory CMC and lifecycle management careers at global pharma MNCs Swiss multinational healthcare giant Novartis is hiring a Regulatory Coordinator for its operations team in Hyderabad, Telangana. In this key regulatory operations role, you will provide operational and compliance support for product development, line extension, and lifecycle management projects, supporting marketing authorizations, post-approval commitments, and Novartis Technical Operations (NTO) site transfers. Core duties include procuring critical regulatory components (Certificate of Pharmaceutical Product - CPP, GMP certificates, Certificates of Analysis - CoAs, registration samples), aligning submission timelines across regional hubs (EU, LACan, MoW, China, Japan), acting as the single point of contact for Regulatory Affairs in NTO governance forums, and tracking dossier deliverables. Candidates holding a Bachelor's or Master's degree in Pharmacy (B.Pharm, M.Pharm) or Life Sciences with minimum 2 years of experience in Regulatory Affairs should apply before 7 August 2026. To format a recruiter-ready professional resume highlighting your CPP procurement, regulatory CMC, and country intelligence capabilities, read our guide on how to apply for healthcare and pharma jobs online. Job Overview Company: IN10 Novartis Healthcare Private Limited / Novartis Job Title: Regulatory Coordinator Department: Global Regulatory Affairs & Technical Operations (NTO) Employment Type: Full-Time, Permanent Required Experience: Minimum 2 Years in Regulatory Affairs or Pharma Industry Application Deadline: Apply Before 7 August 2026 Qualifications: Bachelor's or Master's in Pharmacy (B.Pharm, M.Pharm), Life Sciences, Biotech Key Deliverables: Regulatory Component Procurement (CPP/GMP/CoA), Reg CMC, Lifecycle Maintenance As a Regulatory Coordinator at Novartis, your core duties will include: Regulatory Component Procurement: Timely procure critical submission documents including Certificate of Pharmaceutical Product (CPP), GMP certificates, CoAs, and registration samples in coordination with Health Authorities and consular services. Cross-Functional Submission Alignment: Collaborate closely with RA GDD Development, Reg CMC, Global Labelling, Supply Chain Management (SCM), and Quality Assurance (QA) to enable on-time global submissions. Governance & SPOC Leadership: Act as the single point of contact for Regulatory Affairs in NTO project teams and global/regional governance forums across EU, China, Japan, LACan, and MoW regions. Regulatory Risk Management: Provide regulatory input on submission timelines, identify potential dossier delays, and communicate mitigation strategies proactively. Lifecycle Tracking & Compliance: Track dossier deliverables and post-approval commitments while ensuring strict adherence to global and country-specific regulatory standards. Bachelor's or Master's degree in Pharmacy (B.Pharm, M.Pharm), Life Sciences, Biotechnology, or related scientific discipline. Experience & Key Competencies: Minimum 2 years of experience in Regulatory Affairs, Regulatory Operations, or related areas of the pharmaceutical industry. Hands-on experience in procuring regulatory documents (CPP, GMP, CoAs) and legalizations/consular procedures. Understanding of Regulatory CMC, post-approval changes, and technical operations (NTO) workflows. Strong project management, negotiation, and cross-functional problem-solving skills in a global matrix environment. High agility and proactive approach to delivering outcomes under tight submission deadlines. Highlight CPP & GMP Document Procurement: Explicitly feature your experience procuring Certificates of Pharmaceutical Product (CPP), GMP certificates, and consular legalizations in your resume header. Detail Reg CMC & Technical Operations: Mention your collaboration with Regulatory CMC, supply chain management, and global manufacturing site transfers. Add Technical Keywords: Optimize your CV with terms like Regulatory Coordinator, Regulatory Affairs, CPP Procurement, Reg CMC, Post-Approval Commitments, NTO, and Novartis. Q1. What is a Certificate of Pharmaceutical Product (CPP) and why is it essential for global marketing authorizations Answer Guidance: A CPP is an official WHO-format document issued by a health authority confirming that a medicine is authorized for sale in the exporting country and that the manufacturing plant complies with GMP, required by importing country authorities before granting approval. Q2. How do you manage regulatory procurement risks when consular legalizations face unexpected delays Answer Guidance: I establish early tracking with consular service partners, maintain pre-approved .