Regulatory Affairs Job at Novartis | Life Sciences | Apply Now
Novartis, a world leader in innovative medicine, is seeking a Global Regulatory Submission Manager for its Development unit in Hyderabad, India. This Regulatory Affairs Job is a journey-level, career-oriented position designed for professionals who thrive in the high-stakes world of pharmaceutical documentation and global health authority compliance. Working at Novartis means joining a community dedicated to achieving breakthroughs that change patients’ lives. If you are a life sciences professional with a deep understanding of the drug development lifecycle and eCTD publishing, this Novartis Career opportunity offers the perfect platform to manage complex, large-scale global dossiers.
- Job Position: Global Regulatory Submission Manager
- REQ-10073777
- Location: Hyderabad (Office)
- Research & Development
About the Company
Novartis is a leading global medicines company that uses innovative science and digital technologies to create transformative treatments in areas of great medical need. Their mission is to reimagine medicine to improve and extend people’s lives, focusing on breakthrough therapies that change the standard of care for patients. Headquartered in Basel, Switzerland, Novartis products reach nearly 800 million people globally, supported by a workforce of approximately 100,000+ people representing over 140 nationalities.
Job Overview
- Global Impact: You will manage multiple large and complex global regulatory submission projects, ensuring that life-changing therapies reach patients worldwide.
- Strategic Input: Beyond simple filing, you will contribute to the technical regulatory strategy and intelligence required to develop, register, and maintain global products.
- Operational Excellence: You will drive the implementation of global systems, tools, and processes that support both development projects and marketed products.
- Professional Growth: This is a fully qualified position for a seasoned professional capable of resolving a wide range of issues in creative and innovative ways.
Key Responsibilities
In this Regulatory Affairs Job, you serve as the gatekeeper of a controlled documentation system, ensuring that every record meets the stringent requirements of agencies like the FDA and EMA.
- System Stewardship: Manage electronic records retention processes and the technical/non-technical documentation change system in accordance with global regulatory standards.
- Dossier Assembly: Identify submission components, communicate documentation standards, and coordinate the assembly of complex regulatory dossiers.
- Strategy & Intelligence: Provide the technical regulatory strategy and intelligence required to develop and maintain global products throughout their lifecycle.
- Data Synthesis: Analyze and evaluate complex data to prepare executive summaries and information abstracts of material searched during the submission process.
- Safety Reporting: Ensure the reporting of technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
Key Responsibilities & Requirements
This Life Sciences Job requires a blend of technical expertise in regulatory publishing and high-level project management skills.
- Education: A BS in Life Sciences or a relevant discipline with at least 5 years of professional experience; a Master’s degree is preferred.
- Submission Expertise: 3-5 years of specific experience in Regulatory Affairs or regulatory submissions, including familiarity with global submission formats.
- Regulatory Knowledge: Deep familiarity with global Health Authority regulations and guidances, including FDA regulations, ICH guidelines, and EMA directives.
- Technical Toolkit: Proficiency with computer systems and a demonstrated ability to learn new submission publishing tools and electronic document management systems (EDMS) quickly.
- Project Management: Strong organizational and time-management skills to lead multiple ongoing global projects simultaneously with minimal supervision.
- Collaboration: Effective interpersonal and presentation skills to network with senior internal and external personnel across cross-functional teams.
In summary, the Global Regulatory Submission Manager role at Novartis Hyderabad is a definitive career move for those seeking to lead in the Regulatory Affairs Job market. This position offers the chance to master the complexities of global dossier publishing while contributing to the strategic vision of one of the world’s most innovative pharmaceutical companies. As a “journey-level” role, it provides the autonomy and challenge needed to solidify your expertise in a Novartis Career. If you have the required 5 years of experience and a passion for regulatory excellence, your contributions here will directly support the delivery of medical breakthroughs to patients across the globe.
