Novartis is hiring for the position of QA Compliance Expert – Regulatory CMC Facilitator in Hyderabad, India. This is a full-time role focused on Quality Assurance, regulatory compliance, Chemistry, Manufacturing and Control (CMC), and product lifecycle management.
The position involves working with regulatory teams and global stakeholders to support CMC strategies, evaluate product changes, manage regulatory requirements, and strengthen compliance across the pharmaceutical product lifecycle.
Job Overview
| Job Details | Information |
|---|---|
| Company | Novartis |
| Job Title | QA Compliance Expert – Regulatory CMC Facilitator |
| Job Requisition ID | REQ-10087109 |
| Department/Area | Quality Assurance / Regulatory CMC |
| Location | Hyderabad, India |
| Work Mode | Office / Hybrid |
| Employment Type | Full Time |
| Experience | More than 3 years in a Good Practice regulated environment |
| Qualification | Advanced degree in Chemistry, Biology, Pharmacy, Engineering, or related scientific discipline |
| Industry | Pharmaceutical |
| Relocation Support | Not offered |
Job Description
The QA Compliance Expert – Regulatory CMC Facilitator will support regulatory compliance and product lifecycle activities while working closely with regulatory teams and global stakeholders.
The role focuses on Chemistry, Manufacturing and Control (CMC) requirements, regulatory impact assessments, quality events, compliance discussions, documentation reviews, inspections and process improvement initiatives.
Key Responsibilities
- Work with regulatory teams to align CMC strategies throughout the product lifecycle.
- Assess product changes for their regulatory impact and support appropriate change-control decisions.
- Act as the primary site contact for regulatory-related matters and cross-functional collaboration.
- Provide regulatory guidance during quality events, investigations, escalations and compliance discussions.
- Coordinate timely reviews of CMC documentation for assigned products.
- Support regulatory inspections and audits by identifying and addressing compliance-related risks.
- Lead initiatives aimed at strengthening regulatory compliance and improving process harmonization.
- Conduct training and knowledge-sharing activities to increase regulatory awareness across site functions.
Eligibility / Qualification
Candidates applying for the Novartis QA Compliance Expert – Regulatory CMC Facilitator position should meet the following requirements:
Educational Qualification
An advanced degree in one of the following or a related scientific discipline:
- Chemistry
- Biology
- Pharmacy
- Engineering
- Related scientific discipline
Experience
- More than 3 years of experience in a Good Practice regulated environment.
- Experience in Quality Assurance, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical industry.
Required Skills
Candidates should have knowledge and experience in the following areas:
- Regulatory CMC
- Quality Assurance
- Pharmaceutical regulatory compliance
- Product lifecycle management
- Change control and regulatory impact assessment
- Quality events and investigations
- Regulatory inspections and audits
- CMC documentation
- Good Practice regulated environments
- Biologic drug substance manufacturing
- Recombinant protein manufacturing processes
- Nucleic acid manufacturing processes
- Cross-functional stakeholder collaboration
- Global team collaboration
- Fluent English communication
Additional Requirements
The role requires candidates to:
- Work independently.
- Manage complex priorities.
- Make appropriate quality-related decisions.
- Communicate effectively in English.
- Collaborate with global teams and cross-functional stakeholders.
Job Location
Hyderabad, India
The position is based in the Hyderabad office. Novartis has stated that relocation support is not available, so candidates should apply only if they can access the Hyderabad location.
How to Apply
Interested and eligible candidates can apply online through the official Novartis career application for the position.
Job Title: QA Compliance Expert – Regulatory CMC Facilitator
Job Requisition ID: REQ-10087109
Location: Hyderabad, India
Apply Online: Use the official application link provided with this job posting.
Important Instructions
- This position is based in Hyderabad.
- Novartis does not offer relocation support for this role.
- Candidates should have an advanced degree in a relevant scientific discipline.
- More than 3 years of experience in a Good Practice regulated environment is required.
- Experience in Quality Assurance, Manufacturing, Development or Regulatory Affairs within the pharmaceutical industry is required.
- Knowledge of biologic drug substance manufacturing involving recombinant proteins or nucleic acids is required.
FAQs
1. What is the job title at Novartis?
The position is QA Compliance Expert – Regulatory CMC Facilitator.
2. Where is this Novartis job located?
The position is based in Hyderabad, India.
3. What qualification is required?
Candidates should have an advanced degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
4. How much experience is required?
The job requires more than 3 years of experience in a Good Practice regulated environment.
5. Is relocation support available?
No. The job posting states that Novartis is unable to offer relocation support for this position.
6. What type of experience is required?
Candidates should have experience in Quality Assurance, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical industry, along with knowledge of biologic drug substance manufacturing involving recombinant proteins or nucleic acids.