Regulatory Operations Coordinator / Manager

n-Lorem Foundation; San Diego (CA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

n-Lorem Foundation is seeking a Regulatory Operations Coordinator / Manager in a hybrid role in California. The role reports to VP, ASO Discovery and Development and handles U.S.

regulatory operations across the portfolio, supporting preclinical and clinical teams. The successful candidate will have at least a BSc/MS in science, 3+ years in pharma/biotech or clinical research, and strong FDA/regulatory knowledge.

Qualifications

• BSc or MS degree in a scientific discipline is required.
• Minimum of 3 years of experience in pharmaceutical/biotechnology or clinical research.
• Working knowledge of FDA regulations and guidance relevant to clinical-stage drug development.
• Ability to collaborate effectively across cross-functional teams.
• Demonstrated organizational and project management skills.
• Self-motivated, proactive, and hands-on with 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.
• Coordinate site IRB review and approval with Clinical Development team.
• Prepare and revise internal regulatory procedures for continuous improvement.
• May require up to 10% travel.

Skills

Attention to detail

Cross-functional collaboration

Project management

Self-motivated

Ownership and accountability

Education

BSc or MS in a scientific discipline

Job description

Position Title: Regulatory Operations Coordinator / Manager

Reporting to: Vice President, ASO Discovery and Development

Hours: Full-Time

Location: Hybrid

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

n-Lorem Foundation:

Though n-Lorem 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), we are functionally a biotechnology company. We have a large and growing portfolio of ASO medicine discovery programs, ASO medicines in development and multiple clinical programs.

With a seasoned leadership team and strategic partnerships, the n-Lorem Foundation provides the framework, funds and access for nano-rare patients who are amenable to our technology to receive personalized ASO medicines for free, for life. We hope that you will consider joining us as we strive to change the world, one nano-rare patient at a time.

If you are a professional with strong Regulatory Operations experience and would like to join a cohesive, experienced team committed to the belief that we can change the world one patient, one family at a time, we may have a position for you.

Job Overview:

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. We are seeking an experienced individual with strong attention to detail who is quick and eager to learn, goal-oriented, and self-motivated. The successful candidate will work closely with the preclinical and clinical development teams to implement efficiencies in regulatory operationsacross the n-Lorem portfolio of ASOs. The ability to thrive in a fast-paced biotech-like environment is essential.

Job Duties:

• 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.
• May require up to 10% travel.

Requirements:

• 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.