Regulatory Operations Coordinator / Manager

n-Lorem Foundation is pioneering a novel non-profit model to provide personalized experimental ASO treatments for free, for life to patients with the rarest of mutations (nano-rare). Functionally a biotechnology company, n-Lorem has a large and growing portfolio of ASO medicine discovery programs, ASO medicines in development, and multiple clinical programs. We are seeking an experienced individual with strong Regulatory Operations experience to join a cohesive, experienced team committed to changing the world one nano-rare patient at a time.

About the role

The Regulatory Operations Coordinator / Manager will be responsible for the operational aspects of n-Lorem’s regulatory activities in the U.S., while also supporting the preclinical and clinical development teams in the development, authoring, editing, reviewing, and/or processing of various documents directly or indirectly related to regulatory submissions.

The successful candidate will work closely with the preclinical and clinical development teams to implement efficiencies in regulatory operations across the n-Lorem portfolio of ASOs. The ability to thrive in a fast-paced biotech-like environment is essential.

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.
• Support cross-functional teams in n-Lorem’s global expansion efforts as needed.
• 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.
• May require up to 10% travel.

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.

Pay

$85,000–$110,000 (Compensation may vary based on relevant skills, experience, and qualifications.)

Schedule

Full-Time

Location

Hybrid