Global Regulatory Submission Manager Job at Novartis in Hyderabad for regulatory submissions and global dossier management roles.
Introduction
Regulatory affairs professionals with experience in global submissions and regulatory documentation management can explore an excellent opportunity with Novartis. The company is currently hiring for the position of Global Regulatory Submission Manager at its Hyderabad office.
This role focuses on coordinating and managing complex global regulatory submission projects for pharmaceutical products. The selected candidate will work with cross-functional teams to ensure regulatory dossiers are prepared according to international guidelines and submitted successfully to global health authorities.
The position offers an opportunity to work on global regulatory strategies, documentation systems, and submission processes within a leading pharmaceutical organization. Global Regulatory Submission Manager Job at Novartis
Company Overview
Novartis is a global healthcare company dedicated to reimagining medicine and improving patient outcomes worldwide. The organization develops innovative medicines and therapies that address serious diseases across multiple therapeutic areas.
Novartis operates extensive research, development, and manufacturing facilities around the world and focuses heavily on regulatory compliance, scientific innovation, and patient safety. Regulatory Affairs teams within the company play a critical role in supporting drug development and ensuring pharmaceutical products meet regulatory requirements in international markets.
Working with Novartis provides professionals with exposure to global regulatory strategies, international submission processes, and advanced digital regulatory systems. Global Regulatory Submission Manager Job at Novartis
Job Overview
| Job Details | Information |
|---|---|
| Company Name | Novartis |
| Job Role | Global Regulatory Submission Manager |
| Department | Regulatory Affairs |
| Industry | Pharmaceutical / Life Sciences |
| Job Location | Hyderabad, Telangana, India |
| Employment Type | Full-Time |
| Experience Required | 3 – 5 Years |
| Qualification | Bachelor’s Degree in Life Sciences |
| Application Mode | Online Application |
| Application Deadline | March 26, 2026 |
Job Location & Employment Type
The Global Regulatory Submission Manager role is based in Hyderabad, Telangana, where Novartis operates major global business and technology centers.
This is a full-time position within the regulatory affairs function. The role involves coordinating global regulatory documentation processes, ensuring compliance with international regulatory requirements, and supporting regulatory submissions for pharmaceutical products. Global Regulatory Submission Manager Job at Novartis
Open Positions / Department Details
Position: Global Regulatory Submission Manager
Department: Regulatory Affairs
The Regulatory Affairs department ensures that pharmaceutical products meet regulatory requirements across different global markets. Regulatory submission managers are responsible for preparing and coordinating regulatory documentation needed for product approvals and lifecycle management. Global Regulatory Submission Manager Job at Novartis
Key Roles & Responsibilities
Global Regulatory Submission Management
The primary responsibility of this role is to manage multiple regulatory submission projects across global markets. The candidate will coordinate submission activities and ensure that regulatory dossiers are assembled according to international standards. Global Regulatory Submission Manager Job at Novartis
Regulatory Strategy Support
The submission manager will contribute to the development of regulatory strategies that support the registration and lifecycle management of pharmaceutical products in global markets.
Regulatory Documentation Coordination
The role includes identifying required submission components and coordinating the preparation and assembly of regulatory documentation for global submissions.
Documentation System Management
The candidate will help maintain a controlled documentation system that ensures proper classification, retention, and management of regulatory records in compliance with regulatory requirements.
Data Analysis and Information Extraction
The submission manager may analyze regulatory data, extract key information, and prepare summaries or documentation abstracts required for regulatory submissions.
Global Systems and Process Support
The role also includes supporting the implementation of global regulatory systems, tools, and processes that improve regulatory submission workflows.
Cross-Functional Collaboration
The candidate will work with internal teams such as clinical development, regulatory affairs, quality, and manufacturing to gather required information for submission documentation.
Compliance with Health Authority Guidelines
Ensuring compliance with global regulatory guidelines such as FDA regulations, ICH guidelines, and EMA directives is an important responsibility of this role.
Project Management
Managing multiple ongoing regulatory projects requires strong organizational and time management skills. The candidate will coordinate submission timelines and ensure regulatory deliverables are completed on schedule.
Global Regulatory Submission Manager Job at Novartis
Eligibility Criteria
Candidates interested in applying for this role should meet the following eligibility requirements.
Education
Applicants must possess a Bachelor’s degree in Life Sciences or a related discipline.
A Master’s degree in a relevant scientific field may be preferred.
Experience
Candidates should have 3 to 5 years of experience in regulatory affairs or regulatory submission management.
Experience with global regulatory submission processes and publishing activities will be advantageous. Global Regulatory Submission Manager Job at Novartis
Skills Required
Ideal candidates should demonstrate the following skills:
- Knowledge of global regulatory submission formats and processes
- Understanding of drug development and pharmaceutical regulatory requirements
- Familiarity with regulatory guidelines such as FDA, ICH, and EMA
- Strong project management and organizational skills
- Excellent written and verbal communication abilities
- Analytical and problem-solving skills
- Ability to collaborate with cross-functional teams
Desired Skills
Candidates with the following additional competencies may have an advantage:
- Data analysis and regulatory information management
- Document management systems
- Regulatory compliance expertise
- Understanding of clinical development processes
Salary & Benefits
The salary package for this role has not been publicly disclosed and will be as per company norms.
Employees working at Novartis often benefit from:
- Opportunities to work on global regulatory programs
- Exposure to international pharmaceutical regulatory frameworks
- Professional growth within regulatory affairs leadership roles
- Collaborative and innovative work environment
Global Regulatory Submission Manager Job at Novartis
Selection Process
The recruitment process for this role may include the following stages:
- Online Application Submission
- Profile Screening by HR Team
- Technical Interview
- Leadership or Functional Interview
- Final HR Discussion
Shortlisted candidates will be contacted by the Novartis recruitment team.
How to Apply
Candidates interested in the Global Regulatory Submission Manager role at Novartis can apply through the company’s official careers portal.
Applicants should ensure that their resumes highlight:
- Experience in regulatory submissions and regulatory documentation
- Knowledge of global health authority regulations
- Project management experience in regulatory affairs
- Familiarity with regulatory submission publishing tools or systems
Providing detailed regulatory affairs experience can improve the chances of being shortlisted.
Important Dates
- Job Posted: Recently
- Application Deadline: March 26, 2026
Candidates should submit their applications before the deadline. Global Regulatory Submission Manager Job at Novartis
Why Apply for This Pharma Job?
Global regulatory submission roles provide professionals with valuable exposure to international pharmaceutical regulatory processes. Working in such roles allows candidates to develop expertise in regulatory strategy, documentation management, and global submission coordination.
Joining Novartis offers the opportunity to work on global pharmaceutical development programs and collaborate with regulatory professionals across multiple regions. This experience can lead to career advancement in regulatory affairs, regulatory strategy, and global pharmaceutical compliance roles. Global Regulatory Submission Manager Job at Novartis
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare job updates for informational purposes only.
We do not conduct recruitment or charge any fees for job applications. Candidates should verify job details directly with the official company website before applying. IndiaPharmaJobs.in is not affiliated with Novartis or any organization mentioned in this job posting. Global Regulatory Submission Manager Job at Novartis
Final Call-to-Action
Professionals with experience in regulatory affairs and global submission management should consider applying for this opportunity. Submit your online application before the deadline and ensure your resume highlights expertise in regulatory documentation, submission coordination, and global regulatory compliance to increase your chances of being shortlisted for the Global Regulatory Submission Manager role at Novartis. Global Regulatory Submission Manager Job at Novartis
