Apply for the Novartis Hiring for Regulatory Coordinator Hyderabad. Support global pharmaceutical submissions and ensure regulatory compliance worldwide.
Location: Hyderabad (Office)
Position: Regulatory Coordinator
Organization: Novartis
Employment Type: Full-time
Experience Required: 3–5 Years
Application End Date: November 14, 2025
Are you a detail-oriented professional with a strong understanding of pharmaceutical regulations and compliance? Novartis, one of the world’s leading and most respected pharmaceutical companies, is hiring for the position of Regulatory Coordinator at its Hyderabad office. This is an exciting opportunity for candidates passionate about global regulatory operations, product lifecycle management, and documentation excellence. Novartis Hiring for Regulatory Coordinator
Novartis continues to reimagine medicine and enhance human health through innovation, research, and precision. By joining Novartis as a Regulatory Coordinator, you’ll play an important role in ensuring that the company’s medicines reach patients worldwide while maintaining full compliance with global and local regulatory requirements. Novartis Hiring for Regulatory Coordinator
About the Role
As a Regulatory Coordinator, you will contribute to and support the preparation, submission, and tracking of product registration documents, progress reports, supplements, amendments, and periodic experience reports. This role involves close coordination with internal teams, health authorities, and external partners to ensure all documentation and submissions are aligned with global regulatory standards. Novartis Hiring for Regulatory Coordinator
The ideal candidate will be responsible for assisting in the smooth execution of regulatory projects, maintaining timelines, and ensuring compliance with pharmaceutical regulations. This position requires individuals who are organized, proactive, and capable of working in a matrix-based global environment. Novartis Hiring for Regulatory Coordinator
Key Responsibilities
In this Regulatory Coordinator position at Novartis, your responsibilities will include the following: Novartis Hiring for Regulatory Coordinator
1. Regulatory Submissions and Documentation
- Support the preparation and submission of product registration applications, renewals, and amendments.
- Contribute to product life-cycle maintenance and progress reports, ensuring compliance with the local and global pharmaceutical regulatory environment.
- Manage the collection, organization, and submission of various certificates and regulatory components, such as GMP certificates, COAs (Certificates of Analysis), and registration samples.
2. Coordination with Stakeholders
- Collaborate with multiple internal and external teams including:
- NTO (Novartis Technical Operations)
- Reg CMC (Regulatory Chemistry, Manufacturing & Controls)
- Global Labelling & RA Operations
- Supply Chain Management (SCM)
- Technical Operations for Regulatory Samples
- Liaise with health authorities such as the USFDA, EMA, Swissmedic, and other global regulatory agencies.
- Manage communication with external service providers and consular offices for document authentication and legalization.
3. Planning and Timely Delivery
- Plan and manage the timely delivery of critical regulatory materials such as registration samples, authorized certificates, and supporting documents.
- Ensure all submissions meet health authority requirements and internal quality standards.
4. Project Management and Tracking
- Represent the Regulatory Affairs LCM (Life Cycle Management) BOE team in NTO project meetings and global RA team meetings.
- Track the progress of assigned projects, monitor key milestones, and ensure adherence to submission timelines.
- Coordinate with Country Organizations and Regional Teams to ensure readiness for regulatory submissions and timely product approvals.
5. Quality and Compliance
- Maintain compliance with global regulatory requirements, country-specific rules, and internal Novartis policies.
- Conduct reviews and quality checks of documents before submission.
- Participate in audits and support internal quality assessments.
6. Process Improvement
- Support initiatives to improve regulatory processes, documentation practices, and submission efficiency.
- Contribute to “lessons learned” sessions and cross-functional training programs aimed at refining global regulatory strategies.
- Maintain up-to-date knowledge of evolving global regulatory requirements and communicate changes to relevant teams.
Qualifications and Skills Required
To qualify for the Regulatory Coordinator position at Novartis Hyderabad, candidates should meet the following educational and professional requirements: Novartis Hiring for Regulatory Coordinator
Educational Background
- A degree in Science such as Chemistry, Pharmacy, Biochemistry, Biotechnology, or Biology (or equivalent qualification).
Experience
- Minimum 3–5 years of professional experience in Regulatory Affairs or related areas within the pharmaceutical industry.
- Experience in handling product registration, renewals, or global regulatory submissions preferred.
Technical Skills
- Strong understanding of regulatory submission processes and pharmaceutical documentation.
- Familiarity with GMP (Good Manufacturing Practices), COA handling, and global regulatory guidelines.
- Knowledge of health authority requirements such as USFDA, EMA, and Swissmedic.
Soft Skills
- Excellent communication and interpersonal skills for cross-functional collaboration.
- Strong attention to detail, organization, and documentation precision.
- Effective time management and the ability to prioritize tasks under deadlines.
- Analytical mindset with the ability to identify and solve regulatory challenges.
- Fluency in English, both written and spoken, is mandatory.
Why Join Novartis?
Novartis is not just a workplace — it’s a platform to contribute meaningfully to healthcare innovation. Here’s why this opportunity stands out: Novartis Hiring for Regulatory Coordinator
1. Purpose-Driven Work
At Novartis, every project directly impacts lives around the world. The company’s purpose — to reimagine medicine and improve human health — drives everything it does.
2. Global Exposure
Working at Novartis offers exposure to international regulatory frameworks and collaboration with global teams across continents.
3. Professional Growth
With structured learning and career development programs, employees are encouraged to expand their expertise in pharmaceutical regulations, compliance, and quality management.
4. Inclusive Work Environment
Novartis is deeply committed to diversity, equity, and inclusion. The company values employees from diverse backgrounds and ensures everyone has equal opportunities to grow.
5. Competitive Compensation and Benefits
Employees enjoy attractive salary packages, health benefits, and access to resources that support work-life balance. Detailed information about rewards and benefits is available in the Novartis Life Handbook on their careers page.
Commitment to Diversity and Inclusion
Novartis believes in building an inclusive environment that represents the patients and communities it serves. The company ensures fair hiring practices and a workplace where all voices are valued. Novartis Hiring for Regulatory Coordinator
If you have a medical condition or disability requiring special assistance during the recruitment process or while performing essential job functions, Novartis offers reasonable accommodations. To request accommodation, email diversityandincl.india@novartis.com with your contact details and the job requisition number. Novartis Hiring for Regulatory Coordinator
About Novartis
Novartis is one of the largest pharmaceutical companies in the world, known for its innovation in research, development, and patient care. With a mission to discover new ways to improve and extend lives, Novartis operates in over 150 countries and employs more than 100,000 professionals worldwide. The company continues to pioneer advancements in oncology, cardiovascular medicine, immunology, and neuroscience. Novartis Hiring for Regulatory Coordinator
How to Apply for the Regulatory Coordinator Role
Interested candidates can apply for the Regulatory Coordinator position at Novartis Hyderabad by following the steps below: Novartis Hiring for Regulatory Coordinator
- Visit the official Novartis Careers Page:
https://www.novartis.com/careers - Search for Job Requisition ID:
Enter REQ-10063144 in the search bar. - Review the Job Description:
Carefully go through all job details, including qualifications and responsibilities. - Submit Your Application:
Create or log into your Novartis Careers account and upload your updated resume/CV and relevant certificates. - Stay Connected:
If this role does not match your experience but you’d like to stay informed about future openings, join the Novartis Talent Network here:
https://talentnetwork.novartis.com/network
Final Words
This Regulatory Coordinator position at Novartis Hyderabad is an excellent opportunity for professionals in Regulatory Affairs to advance their careers with a global leader in the pharmaceutical industry. If you’re passionate about contributing to global health and ensuring medicines reach patients safely and effectively, apply before November 14, 2025. Novartis Hiring for Regulatory Coordinator
Join Novartis and become part of a team that’s transforming the future of medicine — one innovation at a time. Novartis Hiring for Regulatory Coordinator
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