Job Description Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to provide advanced support for assigned development, line extension, and lifecycle management projects, including registrations, approvals, post‑approval commitments, and production transfer initiatives driven by Novartis Technical Operations (NTO). The Sr. RC collaborates closely with RA GDD Development and CMC teams, regional stakeholders (MoW, LACan, EU, China, Japan), NTO, and Quality Assurance to align planning, execution, communication, and successful completion of assigned projects. Job Description Major Accountabilities Ensure timely procurement of critical regulatory components (e.g., CPP, GMP certificates, registration samples, CoAs, and other regulatory documents) to support marketing authorization and lifecycle maintenance, in collaboration with internal functions (NTO, Reg CMC, RA Ops, Global Labelling, SCM, Tech Ops) and external stakeholders (Health Authorities, Consular Services, service providers). Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on‑time submissions and approvals. Act as the single point of contact for Regulatory Affairs, representing RA in NTO project teams and global/regional forums and providing regulatory input on requirements, timelines, and risks for new submissions, LENC, and production transfers. Proactively identify regulatory risks, gaps, and trade‑offs, and communicate issues, mitigations, and key achievements to project teams to avoid delays. Track and manage project progress, including timelines, dossier deliverables, and regulatory milestones. Ensure quality and compliance with global and country‑specific regulatory requirements, and adherence to internal policies and processes. Contribute to non‑project initiatives and continuous improvement activities within RA GDD. Drive knowledge sharing and capability building through lessons learned, trainings, and cross‑functional engagements to support aligned regulatory strategies. Ensure clear alignment on roles and responsibilities across internal and external stakeholders. Maintain country requirement intelligence, including requirement lists, surveys, and direct engagement with Country Organizations. Essential Requirements Minimum of 3 years of experience in Regulatory Affairs,related areas of the pharmaceutical Industry Strong communication, interpersonal, negotiation, and problem-solving skills. Proactive, delivery-focused mindset with flexibility to meet stretch targets. Demonstrates agility and speed while maintaining focus on timely outcomes.Effectively plans, prioritizes, and coordinates workloads across teams. Works confidently in a global matrix environment across sites and functions. Build strong, effective relationships across teams and projects. Regulatory operational expertise. Skills Desired Clinical Study Reports, Data Analysis, Document Management, Life Science, Operational Excellence, Regulatory Compliance Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

more at Novartis.

13 Nov, 2026

Novartis

Technicien de Production - Centrale des Pesées / Support Matériel H/F

Huningue

Salary not listed

more at Novartis.

Technicien de Production - Centrale des Pesées / Support Matériel H/F

Medical Science Liaison

Medical Science Liaison

similar roles.

Development Purchasing Specialist

Raw Material SCM Analyst

Mechatroniker / Inbetriebnahmetechniker Maschinenbau (m/w/d)

Vans Arrival Coördinator

Service Adviseur BAS World

Responsable Grands Comptes Retail National (H/F)

more at Novartis.

Technicien de Production - Centrale des Pesées / Support Matériel H/F

Medical Science Liaison

Medical Science Liaison

similar roles.

Development Purchasing Specialist

Raw Material SCM Analyst

Mechatroniker / Inbetriebnahmetechniker Maschinenbau (m/w/d)

Vans Arrival Coördinator

Service Adviseur BAS World

Responsable Grands Comptes Retail National (H/F)