Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Professional I
Job Description
As a Regulatory Professional I, you will have the opportunity to make a significant impact by :
• Working closely with various submission teams across the organisation and all countries in Europe.
• Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials.
• Maintaining documents (uploading and quality checking) in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials.
• Coordinating responses for requests for information from Health Authorities and Ethics Committees.
• Ensuring timely submissions in CTIS and contributing to project team decisions.
• Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs) in the EU.
• Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).
Candidate Profile
• A bachelor’s degree or master’s degree in pharmaceutical or health science.
• Minimum of 5 years’ experience in regulatory affairs or clinical trials.
• Fluent written and spoken English.
• Knowledge of EU CTR and CTIS (including how to upload documents and understanding the full CTIS structure for Part I and Part II).
• Nice to have knowledge of Vault RIM and Vault Clinical (Veeva platforms).
Additional Information
Experience : 5 years
Qualification : B.Pharm, M.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Department : Reg Affairs & Safety Pharmacovigilance
End Date : 15th February 2026
Regulatory Professional : Apply Online >>
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