Regulatory Coordinator Jobs

About The Position

Requirements

• U.S. work authorization.
• BSc or MS degree in a scientific discipline required.
• Minimum of 3 years of experience working in the pharmaceutical, biotechnology. or clinical research industry.
• Working knowledge of FDA regulations and guidance relevant to clinical-stage drug development.
• Strong attention to detail and the ability to maintain accuracy in a fast-paced, evolving environment.
• Demonstrated ability to collaborate effectively across cross-functional teams.
• Demonstrated organizational and project management skills, with the ability to coordinate multiple regulatory activities, manage competing priorities, and consistently meet timelines.
• Self-motivated, proactive, and hands-on, with a strong sense of ownership and accountability.

Responsibilities

• Collaborate with cross functional teams to develop timelines for submissions to regulatory authorities.
• Support the authoring of high-quality regulatory communications, including regulatory meeting requests, briefing packages, responses to regulatory health authority requests, and IND components.
• Track upcoming regulatory milestones, including initial submissions, hold and non-hold responses and annual reports.
• Track, maintain and file all regulatory documentation.
• Gather input from key stakeholders to efficiently respond to inquiries from regulatory agencies in a timely manner.
• Prepare IND annual reports.
• Collaborate with the Clinical Development team to coordinate site IRB review and approval.
• Prepare new clinicaltrials.gov listings and provide annual updates.
• As needed, support cross-functional teams in n-Lorem’s global expansion efforts.
• Provide crisp review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, consistency, and clarity of presentation.
• Develop, maintain, and improve templates for various documents, including nonclinical or clinical protocols, cover letters, pharmacy manuals, IND sections, or others.
• Prepare and revise internal regulatory procedures for continuous improvement.
• Perform other duties as assigned to contribute to the development of the infrastructure needed to support an ever-growing portfolio of programs at various stages.