Job Description Summary
LI-Hybrid

Location: Hyderabad, India

Relocation Support: This role is based in Hyderabad, India. Novartis is unable to offer relocation support: please only apply if accessible.

Join Novartis and play a pivotal role in ensuring patients worldwide receive medicines without interruption. As a QA Compliance Expert - Regulatory CMC Facilitator, you will be at the center of regulatory compliance and product lifecycle management, partnering with global stakeholders to navigate complex Chemistry, Manufacturing and Control requirements. This is an exciting chance to influence strategic decisions, drive regulatory excellence, and support high-quality product delivery while working in a collaborative, international environment where your expertise can make a meaningful impact every day.

Job Description
Key Responsibilities
- Partner with regulatory teams to align Chemistry, Manufacturing and Control strategies across the product lifecycle.
- Evaluate product changes for regulatory impact and support compliant change control decisions.




- Serve as the primary site contact for regulatory matters and cross-functional stakeholder engagement.
- Provide regulatory guidance during quality events, investigations, escalations, and compliance discussions.
- Coordinate timely reviews of Chemistry, Manufacturing and Control documentation for assigned products.
- Support regulatory inspections and audits by identifying and addressing compliance risks.
- Drive initiatives that strengthen regulatory compliance and promote process harmonization.
- Deliver training and knowledge sharing to enhance regulatory awareness across site functions.

Essential Requirements
- Advanced degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
- More than three years of experience in a Good Practice regulated environment.
- Experience in Quality Assurance, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical industry.
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📌 QA Compliance Expert (Hyderabad)
🏢 Novartis
📍 Hyderabad