Novartis Hiring Regulatory Affairs Associate - Hyderabad
Are you seeking high-paying Novartis Regulatory Affairs Jobs or Regulatory Affairs Associate Careers in Hyderabad? Global research-driven pharmaceutical innovator Novartis has announced recruitment for a Regulatory Affairs Associate based at its offices in Hyderabad, Telangana. This full-time position is ideal for candidates with 0 to 2 years of relevant experience.
The selected candidate will support regulatory submissions, coordinate product applications, compile dossiers, and manage licensing updates. To prepare your profile and register successfully, read our detailed tutorial on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Position | Regulatory Affairs Associate |
| Company | Novartis |
| Location | Hyderabad, Telangana (Office) |
| Employment Type | Full-Time |
| Experience Required | Freshers - 2 Years (Relevant experience preferred) |
| Qualifications | Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplines |
| Department | Regulatory Affairs |
| Application Deadline | June 26, 2026 |
| Job ID | REQ-10078046 |
💼 Key Responsibilities
- Prepare, compile, and coordinate high-quality regulatory submissions for product approvals.
- Support Clinical Trial Applications (CTA), New Drug Applications (NDA), and supplemental regulatory applications.
- Maintain up-to-date regulatory dossiers, master archives, and internal databases.
- Ensure timely preparation and submission of product license renewals.
- Support development of Chemistry, Manufacturing, and Controls (CMC), BPI, PSUR, and Risk Management Plan (RMP) files.
- Manage updates to regulatory master files and respond promptly to health authority queries.
- Track registration samples, certificates, dossiers, and follow up with cross-functional teams.
- Maintain complete compliance with company SOPs, regulatory guidelines, and adverse event reporting timelines.
- Collaborate actively with global and regional regulatory affairs stakeholders.
Regulatory dossier compilation requires a solid understanding of study documentation and database management. To learn more about clinical monitoring and trial setups, check our comprehensive Clinical Research Coordinator (CRC) Guide.
🎓 Required Qualifications & Skills
Candidates applying for this Regulatory Affairs role should meet the following eligibility requirements:
- Education: Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm), Life Sciences, Biotechnology, or related disciplines.
- Experience: Freshers to 2 years of relevant experience. Prior internship exposure or regulatory affairs experience is highly preferred.
- Basic understanding of Clinical Trials, Regulatory Submissions, and compliance standards.
For pharmacy and biotech graduates planning their career paths and evaluating global salary scales, check our guide on B.Pharm Career: India vs USA.
Core Competencies
- Knowledge of Regulatory Affairs, submissions, and dossier preparation (CMC, CTA, NDA).
- Excellent document compilation and database management skills.
- Strong attention to detail with proactive problem-solving abilities.
- Excellent written and verbal communication in English.
- Ability to collaborate in global, cross-functional team environments.
💰 Salary & Employee Benefits
- Competitive base salary matching industry standards for entry-level and experienced regulatory professionals at Novartis.
- Direct exposure to international health authorities and global regulatory operations.
- Comprehensive medical insurance and wellness benefits.
- Access to continuous learning programs, career development resources, and global pathways.
- Collaborative and inclusive workplace culture.
To see how drug safety and regulatory compensation compare between India and international regions, read our analysis on Pharmacovigilance Salary: India vs USA.
🌟 Why Join Novartis?
- Novartis is a globally recognized biopharmaceutical leader dedicated to reimagining medicine to improve lives.
- The company provides a supportive and modern workplace that fosters professional growth and innovation.
- A regulatory affairs role at Novartis offers a massive learning curve in international health regulations and submissions.
📑 Resume Tips for Novartis
- Highlight any academic courses, certificates, or internships in Regulatory Affairs, CMC, or drug safety.
- Specify your degree details, GPA, and graduation date clearly.
- Ensure your CV has a clean, professional structure and is optimized for ATS software.
🎯 Novartis Regulatory Affairs Associate Interview Questions
- What are the modules of a Common Technical Document (CTD) and which module contains clinical study reports?
- What is the difference between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA)?
- How do you ensure data integrity when reviewing large volumes of regulatory submissions?
- What is the purpose of Chemistry, Manufacturing, and Controls (CMC) documentation?
- How do you handle multiple projects and prioritize deliverables when deadlines overlap?
📌 How to Apply?
Interested and eligible candidates can submit their applications online directly through Novartis' official Workday job portal using the link below. The application deadline is **June 26, 2026**. To prepare your registration details, read our guide on how to apply for healthcare and pharma jobs online.
🚀 Apply Now
Apply Online❓ Frequently Asked Questions
Q. What is the application deadline?
The application portal is scheduled to close on June 26, 2026.
Q. Who is eligible to apply?
Bachelor’s or Master’s degree graduates in Pharmacy, Life Sciences, Biotechnology, or related fields (Freshers to 2 years experience).
Q. Where is the job location?
The position is full-time, based at Novartis' Hyderabad office in Telangana, India.
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