Novo Nordisk Hiring Regulatory Affairs & Safety Pharmacovigilance Professional

Novo Nordisk Hiring Regulatory Professional – 6 to 8 Years Experience | Bengaluru Global Regulatory Affairs Jobs

Novo Nordisk is hiring Regulatory Professional candidates for its Global Regulatory Affairs (RA Diabetes) team in Bengaluru, Karnataka. This is a full-time opportunity for experienced professionals with 6 to 8 years of expertise in regulatory affairs, global submissions, and lifecycle management. The role focuses on high-level regulatory strategy, global dossier preparation, and health authority interactions, making it a premium career opportunity in pharmaceutical regulatory affairs and drug development.

Company Overview

Novo Nordisk is a globally renowned biopharmaceutical company with over 100 years of leadership in treating chronic diseases such as diabetes, obesity, and rare disorders. With operations in more than 170 countries and a workforce exceeding 60,000 employees, the company is known for its strong scientific foundation, ethical standards, and patient-centric innovation.

The Global Business Services (GBS) division in India plays a critical role in supporting regulatory submissions, clinical development, and global market access strategies. Novo Nordisk is widely respected for its regulatory excellence, high-quality submission standards, and commitment to improving global healthcare outcomes.

Job Role & Responsibilities

As a Regulatory Professional, you will support end-to-end regulatory lifecycle activities, including global submissions, regulatory strategy, and interactions with health authorities. This role requires strong expertise in CTD dossier preparation, labeling, and pharmacovigilance documentation.

Core Regulatory Responsibilities

• Prepare, review, publish, and submit regulatory dossiers (MAA, NDA, BLA, CTA, IND, Device Files)
• Support global regulatory submissions and maintenance of marketing authorizations
• Assist in responses to health authority queries and regulatory interactions
• Maintain regulatory records and submission tracking systems (RIM tools)

Lifecycle Management & Compliance

• Support lifecycle activities including renewals, variations, and post-approval changes
• Contribute to pharmacovigilance documents such as PSUR, DSUR, and Risk Management Plans (RMP)
• Develop and maintain core labeling documents (CCDS, regional and local labels)
• Ensure compliance with global regulatory requirements and guidelines

Regulatory Strategy & Stakeholder Coordination

• Collaborate with cross-functional teams including Clinical, Medical, Safety, Quality, and Commercial teams
• Participate in regulatory meetings, prepare meeting packages, and document minutes
• Support submission planning, timelines, and process optimization initiatives
• Act as a regulatory representative in cross-functional discussions

Process Improvement & Knowledge Sharing

• Contribute to regulatory process improvements and system enhancements
• Share regulatory intelligence and best practices within the team
• Support onboarding, training, and mentoring of team members

Eligibility / Qualifications

Educational Qualification

Candidates must have a postgraduate degree in Life Sciences or related disciplines.

Required courses include:
M.Pharmacy, MSc (Regulatory Affairs, Biotechnology, Microbiology, Biochemistry, Life Sciences), Pharm.D, Biomedical Sciences, Clinical Research

Experience

• 6 to 8 years of experience in regulatory affairs or related fields
• Strong experience in global regulatory submissions and CTD dossier preparation

Skills Required

• Strong knowledge of global regulatory guidelines (FDA, EMA, PMDA)
• Experience with RIM systems and submission planning tools
• Excellent communication, negotiation, and stakeholder management skills
• Strong analytical thinking and problem-solving abilities
• Ability to manage complex regulatory projects and timelines

Location & Salary

• Job Location: Bengaluru, Karnataka, India
• Employment Type: Full-time
• Salary: Competitive salary package with global exposure and career growth opportunities

Application Process

Interested candidates can apply through the official Novo Nordisk careers portal:

Apply Here: https://careers.novonordisk.com/job/Bangalore-Regulatory-Professional-Regulatory-Affairs-Karn/1379770433/

Why This Role Matters in Healthcare

Regulatory Professionals play a vital role in ensuring that innovative medicines reach patients safely and efficiently across global markets. By managing regulatory submissions and lifecycle activities, this role directly contributes to faster drug approvals, improved healthcare access, and regulatory compliance worldwide.

Frequently Asked Questions (FAQs)

1. What experience is required for this role?

Candidates must have 6 to 8 years of experience in regulatory affairs.

2. What qualifications are required?

A Master’s degree in Life Sciences, Pharmacy, or related fields is required.

3. What are the main responsibilities?

The role involves global regulatory submissions, lifecycle management, labeling, and regulatory strategy.

4. Is this a senior-level role?

Yes. This is a mid-to-senior level regulatory affairs position with global exposure.

5. What skills are important for selection?

Regulatory expertise, communication skills, stakeholder management, and ability to handle global submissions.

Summary Table

Category	Details
Company	Novo Nordisk
Vacancies	Regulatory Professional
Required Education	M.Pharmacy, MSc (Regulatory Affairs, Biotechnology, Microbiology, Biochemistry, Life Sciences), Pharm.D, Biomedical Sciences, Clinical Research
Experience	6–8 Years Regulatory Affairs Experience

Tagged as: Pharma Jobs in Bangalore