QA Compliance Expert – Regulatory CMC Facilitator

Novartis India; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Growth For Impact is seeking a Regulatory Affairs professional to partner with regulatory teams, align CMC strategies across the product lifecycle, and evaluate regulatory impact of changes. The role acts as the primary site contact for regulatory matters and engages cross-functionally to ensure compliance.

You will support inspections and drive process harmonization. The ideal candidate has an advanced degree in a scientific discipline, 3+ years in a Good Practice regulated environment, and

Qualifications

• Experience in Good Practice regulated environment.
• Fluent English communication and cross-functional collaboration.

Responsibilities

• Coordinate regulatory strategies across product lifecycle.
• Evaluate regulatory impact of product changes and support change control decisions.
• Act as primary site contact for regulatory matters and stakeholder engagement.
• Provide regulatory guidance during quality events and investigations.
• Coordinate reviews of Chemistry Manufacturing and Control documentation.
• Support regulatory inspections and audits and address compliance risks.
• Drive initiatives to strengthen regulatory compliance and harmonize processes.
• Deliver regulatory training and knowledge sharing across site functions.

Skills

Quality Assurance

Regulatory Affairs

Manufacturing

Education

Advanced degree in Chemistry/Biology/Pharmacy/Engineering

Job description

ROLE

• 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.

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.