Associate Regulatory Professional II

The position

• As Associate Regulatory Professional II you will play a crucial role in driving coordinating and actively following up on multiple tasks with challenging timelines. Your responsibilities will include:
• Working closely with various submission teams across the organization 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 QC) 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).

Qualifications

We expect you to have:

• Bachelors degree masters degree or Ph.D. in science pharmaceutical or health science.
• At least 3 years of experience in regulatory affairs or clinical trials.
• Fluent written and spoken English.
• Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage.

On personal level :

Strong team player.

• Well organised structured and detailed oriented
• Have solid problemsolving capabilities.
• Can keep your spirits high even when under pressure.
• Skilled communicator who can cooperate at any organisational level.
• Curios and like learning new things.
• You love data and working in systems.
• Enjoy working with people online and want to be part of virtual multicultural team.

Please use the below link for job application and quicker response.

Remote Work :

No