Novo Nordisk Hiring Associate Regulatory Specialist & Medical Writer
Novo Nordisk Global Business Services (GBS) has announced exciting opportunities for Associate Regulatory Specialist and Medical Writer positions in Bangalore. These openings are ideal for professionals interested in Regulatory Affairs, Medical Writing, Clinical Development, Pharmacovigilance, Regulatory Submissions, and Drug Development.
Candidates from Pharmacy, Life Sciences, Clinical Research, Medicine, and Regulatory Affairs backgrounds are encouraged to apply.
📋 Job Overview
| Details | Information |
|---|---|
| Company | Novo Nordisk GBS |
| Location | Bangalore, Karnataka |
| Positions | Associate Regulatory Specialist & Medical Writer |
| Employment Type | Full-Time |
| Experience | 2–9+ Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D, MSc, MBBS, MD, PhD |
🏢 About Novo Nordisk
Novo Nordisk is a global healthcare company focused on defeating serious chronic diseases including diabetes, obesity, and rare blood disorders. The company operates in more than 170 countries and is recognized worldwide for innovation, patient-centric healthcare solutions, and scientific excellence.
📌 Position 1: Associate Regulatory Specialist
This role supports global regulatory submissions, lifecycle management activities, health authority interactions, and regulatory strategy execution across international markets.
Key Responsibilities
- Support global regulatory submission activities.
- Manage NDA, BLA, MAA, CTA, IND, PIP, PSP, DSUR, PSUR, and RMP submissions.
- Coordinate interactions with FDA, EMA, PMDA, and global authorities.
- Support labeling lifecycle management.
- Prepare briefing documents and regulatory responses.
- Participate in regulatory due diligence activities.
- Drive process improvement initiatives.
- Collaborate with cross-functional development teams.
Required Qualification
- Bachelor's, Master's, PharmD, or PhD in Life Sciences.
- 7–9+ years Regulatory Affairs experience.
- Knowledge of EU, US, China, and Japan regulations.
- Regulatory submission and lifecycle management experience.
📌 Position 2: Medical Writer
The Medical Writer role focuses on developing high-quality clinical and regulatory documents supporting global clinical development programs.
Key Responsibilities
- Prepare Clinical Study Protocols.
- Develop Clinical Study Reports (CSR/CTR).
- Create Investigator Brochures (IB).
- Author CTD Module 2 documents.
- Draft regulatory responses and Q&A packages.
- Collaborate with Clinical, Safety, Statistics, and Regulatory teams.
- Maintain compliance with global writing standards.
Required Qualification
- MSc, M.Pharm, PharmD, MBBS, MD, PhD.
- Minimum 2 years Medical Writing experience.
- Strong scientific writing skills.
- Knowledge of ICH and global regulatory guidelines.
💡 Skills Required
- Regulatory Affairs
- Medical Writing
- Clinical Development
- Regulatory Submissions
- Pharmacovigilance
- Clinical Reporting
- Regulatory Documentation
- Veeva Vault RIM
- ICH Guidelines
- Stakeholder Management
- Scientific Writing
- Lifecycle Management
🌍 Global Regulatory Exposure
Professionals joining Novo Nordisk will gain exposure to major global regulatory agencies including FDA, EMA, PMDA, and other international health authorities while supporting innovative therapies for chronic diseases.
🌟 Why Join Novo Nordisk?
- Work with one of the world's leading pharmaceutical companies.
- Contribute to therapies impacting millions of patients globally.
- Exposure to international regulatory and clinical development projects.
- Strong learning and development culture.
- Excellent work-life balance and employee benefits.
- Global career growth opportunities.
- Collaborative and innovation-driven work environment.
- Opportunity to work with leading experts in healthcare and life sciences.
📈 Regulatory Affairs Career Path
- Regulatory Affairs Associate
- Associate Regulatory Specialist
- Regulatory Affairs Specialist
- Senior Regulatory Specialist
- Regulatory Affairs Manager
- Global Regulatory Lead
- Director – Regulatory Affairs
- Vice President – Regulatory Affairs
✍️ Medical Writing Career Path
- Medical Writer
- Senior Medical Writer
- Principal Medical Writer
- Scientific Writing Lead
- Medical Writing Manager
- Associate Director Medical Writing
- Director Medical Writing
📝 Resume Tips
- Highlight Regulatory Affairs or Medical Writing experience.
- Mention CTD, CSR, Protocol, IB, and submission experience.
- Include experience with FDA, EMA, PMDA, or global agencies.
- Showcase scientific writing and analytical skills.
- Mention Veeva Vault RIM or regulatory systems exposure.
- Use ATS-friendly formatting.
- Quantify achievements wherever possible.
📌 Before applying, read:
👉 Healthcare & Pharma Application Guide🎯 Interview Preparation Tips
- Review ICH guidelines and regulatory frameworks.
- Understand CTD structure and submission processes.
- Prepare examples of regulatory submissions handled.
- Revise clinical study report and protocol writing concepts.
- Learn about Novo Nordisk products and therapeutic areas.
- Prepare for scenario-based stakeholder management questions.
- Practice scientific writing and document review concepts.
❓ Common Interview Questions
For Regulatory Affairs
- What is CTD and eCTD?
- Explain NDA, BLA, MAA, and IND.
- How do you manage lifecycle submissions?
- What is your experience with health authority interactions?
- What are DSUR and PSUR?
For Medical Writing
- How do you prepare a Clinical Study Report?
- What is an Investigator Brochure?
- Explain CTD Module 2.
- How do you ensure scientific accuracy?
- How do you manage multiple writing projects simultaneously?
📄 Documents Recommended Before Applying
- Updated Resume
- Educational Certificates
- Experience Certificates
- Latest Salary Documents
- Scientific Publications (if available)
- Writing Samples (for Medical Writers)
- Updated LinkedIn Profile
- Government ID Proof
👨⚕️ Who Should Apply?
- Regulatory Affairs Professionals
- Medical Writers
- Clinical Research Professionals
- Pharmacovigilance Professionals
- PharmD Graduates
- M.Pharm Graduates
- Life Sciences Professionals
- MBBS, MD, and PhD Candidates
📚 Recommended Resources
👉 Pharma Knowledge Hub👉 Healthcare Quiz Collection
👉 Clinical Research Quiz
👉 Pharmacovigilance Quiz
👉 Pharma Interview Questions
❓ Frequently Asked Questions (FAQ)
Q1. What is the experience requirement for Medical Writer?
Minimum 2 years of Medical Writing experience.
Q2. What is the experience requirement for Associate Regulatory Specialist?
Approximately 7–9+ years of Regulatory Affairs experience.
Q3. Which qualifications are eligible?
B.Pharm, M.Pharm, Pharm.D, MSc, MBBS, MD, PhD, and Life Sciences qualifications.
Q4. What are the application deadlines?
18 June 2026 for Associate Regulatory Specialist and 19 June 2026 for Medical Writer.
Q5. Is global regulatory experience preferred?
Yes. Experience with FDA, EMA, PMDA, and international regulatory agencies is highly valued.
🚀 How to Apply
Interested and eligible candidates can apply through the official Novo Nordisk careers portal.
🚀 Apply – Associate Regulatory Specialist✍️ Apply – Medical Writer
🗓️ Associate Regulatory Specialist: 18 June 2026
🗓️ Medical Writer: 19 June 2026
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