Associate Director

The Company:

Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position:

Associate Director/Director, Regulatory Systems

Reports to: Senior Director, Regulatory Affairs

Position Overview

The Regulatory Systems Associate Director/Director will be responsible for the implementation, validation and day to day management of regulatory systems, including maintenance, training, and end-user support. In this role, Regulatory Systems Associate Director/Director will liaise with system vendors and oversee product updates in conjunction with internal stakeholders, specifically Quality Assurance and Information Technology. The Regulatory Systems Associate Director/Director will ensure that regulatory systems will align with the requirements of Regulatory Affairs and adjacent systems, employing cross-functional collaboration with business users to understand business needs, address system issues, and recommend process improvements based on experience from day-to-day operations. As part of the Regulatory Operations team, the Regulatory Systems Associate Director/Director will support submission publishing, management of regulatory information, and other regulatory operations activities as needed.

Key Responsibilities

• Implementation and validation of regulatory systems, inclusive of management of vendors, in collaboration of Quality operations and Information technology
• Administration of regulatory systems, including maintenance, user management, training, and issue escalation and resolution
• Developing and maintaining standard operating procedures (SOPs) and work instructions (WIs) relevant to use of regulatory systems
• Ensuring compliance with SOPs and WIs, addressing deviations, and developing and executing corrective actions and preventative actions related to use of regulatory systems
• Provide support, training, and direction to end users
• Deliver regulatory systems projects on time and on budget and ensure that day-to-day support needs meet business expectations
• Assist in developing regulatory information management landscape and related roadmap
• Design, implement, and disseminate standard, validated, and ad-hoc reports to meet regulatory and other compliance requirements
• Manage and oversee development of training materials, quick reference guides, FAQs, and other reference documents to facilitate systems use
• Manage change request development for regulatory systems and ensure appropriate communication and business change management
• Monitor the development of new regulatory requirements or guidance regarding regulatory systems and recommend system changes as appropriate
• Lead upgrade s and maintenance of regulatory systems, including validation activities
• Communicate system status and maintenance activities and liaise with Information Technology and vendors to address extended support, hyper-care, and disaster recovery.
• Assist in and support submission publishing, the management of regulatory information, and other Regulatory Affairs activities as needed

Key Experience, Skills, and Knowledge

• Minimum of 4-year undergraduate degree
• 8 - 10+ years experience in a Regulatory Affairs system support role in the pharmaceutical industry
• Understanding of GxP systems and quality principles
• Ability to research global regulatory guidance and technical initiatives to assist in the development and execution of regulatory system strategies.
• Knowledge of eCTD structure, components, and basic regulatory operations in support of regulatory submissions
• Experience with preparation (authoring and review) of documents for health authority submissions including but not limited to investigational new drug amendments, clinical trial and biologic license submissions, and health authority meeting requests and supporting dossiers
• Excellent communication, time management and project management skills
• Continuous quality improvement mindset and attention to detail
• Ability to adapt to changing priorities and objectives in a fast-paced environment.

Benefits

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

Equal Opportunity Employment

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

PI6971f6fb0ae2-25405-36208471