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Opportunity to work as RA CMC Submission Coordinator at Novartis-Apply before 30th April 2025

Novartis
Pharmacareer

Website Novartis

Job Title: RA CMC Submission Coordinator
Location: Hyderabad, India
Company: Novartis
Job ID: REQ-10047824
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 30th April 2025

🚀 Join One of the Most Rewarding Employers in the Industry

At Novartis, innovation meets purpose. With one of the most promising pipelines in the pharmaceutical world, we bring groundbreaking medicines to life—powered by a diverse, talented, and performance-driven team.

🧪 About the Role

As a RA CMC Submission Coordinator, you’ll play a critical role in supporting regulatory Chemistry, Manufacturing, and Controls (CMC) operations. Your efforts will help ensure high-quality, timely submissions that support global regulatory strategies across the product lifecycle.

📋 Key Responsibilities

  • Conduct regulatory compliance activities such as quality checks, document assurance (DA) reviews, and IND annual report preparation

  • Serve as a point of contact for CMC-related queries and maintain accurate data in regulatory databases

  • Prepare and organize submission documentation (e.g., metadata forms, folder structures, RA requests)

  • Ensure documentation is compliant with eCTD standards and finalize it for submission

  • Track and report CMC submission data and KPIs

  • Coordinate document finalization, gather ancillary materials, and manage submissions via appropriate systems

  • Act as a super-user for RA CMC systems and support account requests or modifications

  • Acquire and maintain GMP Certificates and Manufacturing Authorizations

  • Collaborate with Global Submission Operations Center (GSOC) colleagues for end-to-end submission coordination

🎯 Performance Indicators

  • Delivery of high-quality, timely regulatory submissions

  • Compliance with Novartis and eCTD guidelines

  • Clear communication and effective coordination across teams

  • Strong stakeholder collaboration and business continuity support

🎓 Candidate Profile

Minimum Education:

  • General qualification for university entrance or completed vocational training

Preferred Education:

  • Bachelor’s degree in Science (Pharmacy, Chemistry, Biotechnology, Biology, Biochemistry) or equivalent

Language Proficiency:

  • Fluent in English (written and spoken)

🧠 Experience & Skills

Experience:

  • With vocational training: Minimum 2 years in regulatory or pharma industry

  • With science degree: Minimum 1 year in regulatory or pharma industry

  • Experience with pharmaceutical data systems and regulatory data management

  • Exposure to publishing tools is a plus

Technical & Soft Skills:

  • Proficient in IT systems and data processing

  • Strong planning, organizational, and interpersonal abilities

  • Comfortable working in global teams and managing multiple priorities

Core Competencies:

  • Being Resilient

  • Digital & Technology Savvy

  • Continuous Learning

  • Interpersonal Savvy

  • Operational & Project Excellence

🌟 Why Novartis?

Because every role here is a chance to make a meaningful impact. You’ll be part of a global mission to reimagine medicine and deliver better outcomes for patients worldwide.

Apply now and be part of a purpose-driven organization where your work truly matters.

To apply for this job please visit www.novartis.com.