QA Compliance Expert - Regulatory CMC Facilitator

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; Hybrid; INR 1,500,000 - 2,600,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad, India, is seeking a QA Compliance Expert - Regulatory CMC Facilitator to lead regulatory compliance efforts across the product lifecycle. The role partners with global stakeholders to navigate complex CMC requirements and drive regulatory excellence.

This Band 4 position emphasizes independent work, strong QA decision-making, and collaboration in an international environment to ensure high-quality product delivery.

Qualifications

• Advanced degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
• 3+ years in a Good Practice regulated environment.
• Experience in QA, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of biologic drug substance manufacturing processes involving recombinant proteins or nucleic acids.
• Ability to work independently, manage complex priorities, and make sound quality decisions.
• Fluent English communication and collaboration across global teams.

Responsibilities

• Partner with regulatory teams to align CMC 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 engagement.
• 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 risks.
• Drive initiatives that strengthen regulatory compliance and promote process harmonization.
• Deliver training and knowledge sharing to enhance regulatory awareness across site functions.

Skills

Independent working

Regulatory collaboration

English communication

Education

Advanced degree in Chemistry/ Biology/ Pharmacy/ Engineering

Job description

Band Level 4 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 opportunity 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.
• Strong knowledge of biologic drug substance manufacturing processes involving recombinant proteins or nucleic acids.
• Ability to work independently, manage complex priorities, and make sound quality decisions.
• Fluent English communication skills with the ability to collaborate across global teams.

Why Novartis:

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.

With our people. It is our associates that drive us each day to reach our ambitions.

Be a part of this mission and join us!

Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

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.

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 .