Regulatory Affairs Documentation Specialist

Job summary

This role involves supporting regulatory submissions for a significant obesity program, focusing on the operational delivery of various submission types including CTA, IND, NDA, MAA, and PIP. The position requires collaboration with cross-functional teams and external stakeholders to ensure the production of high-quality, submission-ready documentation.

Qualifications

• Relevant experience in regulatory affairs/documentation within the pharmaceutical industry
• Familiarity with health authority submissions
• Experience using Veeva RIM and Clinical Trials Information System (CTIS)
• Strong stakeholder management skills, particularly in coordinating with CROs and publishers
• High attention to detail and excellent organizational skills to manage multiple timelines
• Fluency in English, both written and spoken

Responsibilities

• Plan, coordinate, and execute regulatory submissions in alignment with regulatory strategy
• Communicate and coordinate with assigned CROs and external vendors
• Manage health authority submissions including Q&A, DSUR, IB, and Annual Reports
• Maintain regulatory trackers and logs, ensuring proper archiving of documents in Veeva RIM
• Serve as a subject matter expert for CTIS, representing Regulatory Affairs in working groups

Skills

• Strong organizational and communication skills
• Ability to manage multiple stakeholders and deadlines
• Proactive and collaborative mindset

Education

• Not specified

Tools

• Veeva RIM
• Clinical Trials Information System (CTIS)