Regulatory Professional I
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Bangalore • India
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Tech Stack
About the role
- 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).
Requirements
- 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)
Benefits
- Collaborative and supportive environment
- Dynamic and diverse workplace
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsclinical trialsclinical trial application submissionsdocument quality checkingdata managementprocess setupknowledge of EU CTRknowledge of CTISuploading documentsunderstanding CTIS structure
Soft skills
collaborationcommunicationproject managementorganizational skillsattention to detail
Certifications
bachelor’s degree in pharmaceutical sciencemaster’s degree in health science