Novo Nordisk Recruitment 2026: Regulatory Professional I (EU CTR Specialist)

Novo Nordisk, a global healthcare giant with nearly a century of leadership in diabetes and biopharmaceuticals, is hiring for its Regulatory Affairs & Safety team in Bangalore. This role is a prime opportunity for pharmaceutical professionals to specialize in the complex landscape of European clinical trial regulations.

The Regulatory Professional I will play a critical role in managing the lifecycle of clinical trials across Europe, ensuring that life-saving research meets the stringent requirements of the European Union Clinical Trial Regulation (EU CTR).

Key Responsibilities & Impact

This position focuses on the digital and regulatory management of clinical trials through the Clinical Trial Information System (CTIS).

CTA Submissions: Manage initial Clinical Trial Applications (CTAs) and handle all subsequent lifecycle changes across all EU member states.
CTIS Management: Act as a subject matter expert for the CTIS platform, responsible for uploading, quality-checking documents, and maintaining accurate trial data.
Health Authority Interaction: Coordinate and draft responses to Requests for Information (RFIs) from Health Authorities and Ethics Committees.
Process Innovation: Participate in shaping and optimizing new internal processes for EU CTA submissions.
System Collaboration: Utilize advanced Regulatory Information Management (RIM) platforms, including Veeva Vault RIM and Vault Clinical.

Candidate Profile

Novo Nordisk is looking for a professional with a deep understanding of the technical structure of EU clinical filings.

Criteria	Requirement
Education	B.Pharm or M.Pharm (or other Health Sciences degree).
Experience	Minimum 5 years in Regulatory Affairs or Clinical Trials.
Core Knowledge	Expert knowledge of EU CTR and the CTIS structure (Part I and Part II).
Tech Stack	Proficiency in Veeva Vault RIM and Vault Clinical (highly desirable).
Languages	Fluent written and spoken English.

Additional Information

Location: Bangalore, Karnataka.
Department: Regulatory Affairs & Safety Pharmacovigilance.
Industry: Pharma / Clinical Research.
Application Deadline: 15 February 2026.

How to Apply

Interested candidates should apply through the Novo Nordisk Global Careers site. Given the specific nature of this role, ensure your resume highlights your direct experience with CTIS portal navigation, Part I/II document preparation, and any previous work with Veeva platforms.