Regulatory CMC Compliance Facilitator
By Admin · Regulatory Affairs
ROLE OVERVIEW
Novartis is seeking a Regulatory CMC Compliance Facilitator to serve as a critical bridge between quality assurance, manufacturing, and global regulatory affairs at its Hyderabad hub. In this hybrid role, you will help ensure that biologic drug substance changes, submissions, and lifecycle events remain compliant with evolving global health authority expectations. The position is central to preventing supply interruptions and accelerating patient access to innovative recombinant protein and nucleic acid therapies. By evaluating CMC documentation, guiding change control, and supporting inspections, you will directly influence product quality and regulatory success. For experienced pharmaceutical professionals, this is a rare chance to work across international teams, deepen CMC and GxP expertise, and shape compliance strategies for a leading medicines company.
ROLE DEFINITION & RESPONSIBILITIES
- •Partner with global regulatory teams to define and align CMC strategies across the product lifecycle, from early development through post-approval variations and renewals.
- •Evaluate manufacturing, analytical, and quality changes for regulatory impact, ensuring change control decisions are compliant, risk-based, and thoroughly documented.
- •Serve as primary site contact for regulatory CMC matters, coordinating cross-functional responses with QA, manufacturing, development, and external partners.
- •Provide regulatory guidance during quality events, investigations, deviations, escalations, and compliance discussions to mitigate risks and prevent recurrence.
- •Coordinate timely review, compilation, and approval of CMC documentation for assigned products, maintaining audit-ready and inspection-ready records.
- •Support health authority inspections and internal audits by identifying compliance gaps, drafting responses, and implementing corrective and preventive actions.
- •Drive process harmonization initiatives and deliver training to enhance regulatory awareness and GxP compliance across site functions.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Advanced degree (MSc, MPharm, PhD, or equivalent) in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
- More than three years of experience in a Good Practice (GxP) regulated pharmaceutical environment.
- Proven background in Quality Assurance, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical or biotech industry.
- Strong knowledge of biologic drug substance manufacturing, including recombinant proteins or nucleic acid-based modalities.
- Demonstrated ability to work independently, manage complex priorities, and make sound quality and compliance decisions.
- Fluent English communication skills with the ability to collaborate effectively across global, cross-functional teams.
- Experience with regulatory inspections, audits, and CMC documentation review is highly valued.
PREFERRED QUALIFICATIONS
- •Recombinant Protein & Nucleic Acid Therapeutics
- •Veeva Vault / TrackWise / SAP Quality Modules
- •Regulatory Submission Formats (CTD/eCTD)
- •Deviation, CAPA & Investigation Management
- •Lean Six Sigma / Process Harmonization
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Novartis AG is a Swiss multinational pharmaceutical corporation, one of the largest in the world. It focuses on discovering, developing, manufacturing, and marketing innovative medicines to address significant health needs. The company's portfolio spans various therapeutic areas including oncology, immunology, neuroscience, and cardiovascular diseases.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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