Global pharmaceutical leader Novo Nordisk has announced recruitment for Medical Writer and Associate Regulatory Specialist positions at its Global Business Services (GBS) center in Bangalore, Karnataka. These opportunities are ideal for professionals seeking careers in regulatory affairs, medical writing, clinical development, pharmacovigilance, regulatory submissions, and drug development.

Candidates with backgrounds in life sciences, pharmacy, medicine, clinical research, and regulatory affairs are encouraged to apply. These roles offer the opportunity to work on global clinical development programs and regulatory strategies supporting innovative therapies for chronic diseases, including diabetes.

Job Highlights

1. Associate Regulatory Specialist – Regulatory Affairs (Diabetes)

Job Overview

Novo Nordisk is seeking experienced regulatory professionals to support global regulatory submissions, health authority interactions, lifecycle management activities, and labeling strategies for its diabetes portfolio. The role involves collaboration with global stakeholders including FDA, EMA, PMDA, and other regulatory authorities.

Key Responsibilities

• Develop and execute regulatory submission plans using Vault RIM.
• Manage NDA, BLA, MAA, CTA, IND, PIP, PSP, DSUR, PSUR, and RMP submissions.
• Coordinate interactions with global health authorities including FDA, EMA, and PMDA.
• Prepare meeting packages, briefing documents, and regulatory responses.
• Support core labeling development and lifecycle management activities.
• Conduct regulatory due diligence assessments.
• Drive process improvements and regulatory excellence initiatives.
• Participate in clinical project teams and cross-functional development programs.

Required Qualifications

• Bachelor’s, Master’s, PharmD, or PhD in Life Sciences or related field.
• 7–9+ years of Regulatory Affairs experience.
• Strong knowledge of regulatory requirements across EU, US, China, and Japan.
• Experience with global regulatory submissions and lifecycle management.
• Understanding of pharmacovigilance, clinical pharmacology, and patient access strategies.
• Excellent communication and stakeholder management skills.

Preferred Skills

• Regulatory intelligence expertise.
• Health authority interaction experience.
• Labeling strategy development.
• Device development knowledge.
• Regulatory documentation management.

2. Medical Writer – Clinical Reporting

Job Overview

Novo Nordisk is hiring Medical Writers to support global clinical development programs through preparation of clinical and regulatory documents. The role focuses on delivering high-quality scientific content aligned with regulatory requirements and clinical reporting strategies.

Key Responsibilities

• Prepare Clinical Study Protocols.
• Author Clinical Study Reports (CSRs/CTRs).
• Develop Investigator Brochures (IBs).
• Prepare CTD Module 2 summaries and overviews.
• Draft regulatory response documents and Q&A packages.
• Collaborate with clinical, statistical, regulatory, and safety teams.
• Maintain compliance with global regulatory writing standards.
• Support process improvement and knowledge-sharing initiatives.

Required Qualifications

• MSc, M.Pharm, PharmD, MBBS, MD, PhD, or equivalent qualification.
• Minimum 2 years of regulatory medical writing experience.
• Experience preparing regulatory and clinical documents.
• Strong scientific writing and analytical skills.
• Excellent written and verbal English communication skills.
• Ability to manage multiple projects and deadlines.

Preferred Skills

• Clinical reporting expertise.
• Regulatory submission document writing.
• Cross-functional stakeholder management.
• Knowledge of ICH and global regulatory guidelines.

Why Join Novo Nordisk?

Novo Nordisk is one of the world’s leading healthcare companies dedicated to defeating serious chronic diseases. Employees benefit from:

• Global career development opportunities.
• Exposure to international regulatory and clinical projects.
• Collaborative and inclusive work culture.
• Continuous learning and professional growth.
• Competitive compensation and employee benefits.
• Opportunity to impact millions of patients worldwide.

How to Apply

Application Link For Associate Regulatory Specialist

Application Link For Medical Writer