Description
Your Day-to-Day:
Assist in the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) to regulatory authorities
Manage and contribute to major and routine regulatory submissions, as assigned, including amendments, responses to questions from health authorities, and ensure timely updates to regulatory documents
Conduct in-depth regulatory research to propose strategic advice on regulatory matters
Stay up-to-date with regulatory guidelines, policies, and best practices related to clinical trials and drug development
Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance
Contribute to the development and continuous improvement of regulatory affairs processes and best practices
Lead the preparation and coordination of responses to health authority questions (FDA, EMA,PMDA, etc.) in collaboration with cross-functional teams.
Participate in the planning and execution of health authority meetings, ensuring alignment on regulatory strategy and documentation quality.
Partner closely with cross functional teams to ensure regulatory deliverables align with overall study timelines and objectives.
Coordinate with CROs and external vendors to ensure consistent regulatory compliance across global trial sites and submissions.
Track submission and approval status globally, providing regular updates and reports to leadership.
This role is based in the Financial District in Boston. This role is hybrid and is required onsite Monday-Wednesday.
Requirements
Bachelors degree in life sciences or related discipline
8+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology
Proven experience with Global CTA submissions and IND maintenance
Strong knowledge of regulatory guidelines and clinical trial regulations
Ability to manage multiple priorities and work in a fast-paced, dynamic environment
Proficient working with regulatory submission software
Proactive, self-motivated, and able to work independently
Strong interpersonal skills and alignment with Rapport’s values and company culture
