Larimar Therapeutics

Description: About Us: Larimar Therapeutics Inc. 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 (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. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar. Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes. CMC Documentation, Submissions and HA interactions Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar's regulatory submission timing and strategy With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting. Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model. Can do attitude, flexibility, and mental agility Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and 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. PIde713f1d658c-7779

The Company: 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. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein, to the mitochondria of patients with Friedreichs ataxia. Friedreichs ataxia is a rare, progressive and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 75 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 (GMPs). The companys strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their teams know how and expertise to the development of nomlabofusp and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Description This position will be part of the Analytical Sciences Team within the Larimar Technical Operations Group. The person who fills this role should have knowledge in analytical method development, transfer, qualification and QC stability in support of the manufacture of a recombinant fusion proteins expressed in E. coli fermentation systems at Larimars external manufacturing partners. In this fast-paced environment, the person who fills this role will have the opportunity to develop scientifically and gain insight into other areas of the business. Job Responsibilities The responsibilities may include, but are not limited to, the following activities: Generation of internal certificates of analysis, shelf-life letters, and other relevant internal documents. Review of routine OOS reports, deviations, change controls and QC data generated from External Laboratory partners. Review of vendor CoAs, data verification for internal CoAs and regulatory filings Review of Analytical test methods, transfer protocols, qualification protocols and associated reports. Keeps abreast of current regulatory and industry guidelines to support the on-going clinical development and to ensure compliance across multiple regulatory jurisdictions. Work closely with contract service provider (CSP) Quality Control testing groups to support assay troubleshooting where needed. Full understanding of selection, characterization, and maintenance of Reference Standard Program. Including generation of protocols, data review and statistical analysis of data generated. Responsible for generating the reports associated with the program. Draft technical reports to summarize development and assay qualification studies. Can work in a team environment but can also take ownership of large technical reports and projects. Qualifications MS/BS/BA within Biology, Biochemistry, Cell Biology, or related field (Cell Biology, Biology or Biochemistry preferred) and 4 to 8 years experience required GxP experience in a Quality Control or Analytical Development laboratory with experience or first-hand knowledge in analytical method development and qualification under ICH/FDA guidelines is required. Experience working under global regulatory agencies such as the EMA and HC is highly desirable. Mastery of the Microsoft Office Suite (Word, Excel, PowerPoint) required Strong written and verbal communications skills required Experience working with electronic quality management systems is desired. Willingness to take on new and unfamiliar tasks. Must be able to navigate in a fast-paced environment and have the ability to prioritize multiple objectives appropriately Benefits Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and employees are made in a non-discriminatory mannerwithout 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. PI89f8442bb2-

The Company: 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. Their lead product candidate, nomlabofusp, 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 has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 75 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 (GMPs). 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 and expertise to the development of nomlabofusp and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Description This position will be part of the Analytical Sciences Team within the Larimar Technical Operations Group. The person who fills this role should have knowledge in analytical method development, transfer, qualification and QC stability in support of the manufacture of a recombinant fusion proteins expressed in E. coli fermentation systems at Larimar's external manufacturing partners. In this fast-paced environment, the person who fills this role will have the opportunity to develop scientifically and gain insight into other areas of the business. Job Responsibilities The responsibilities may include, but are not limited to, the following activities: Generation of internal certificates of analysis, shelf-life letters, and other relevant internal documents. Review of routine OOS reports, deviations, change controls and QC data generated from External Laboratory partners. Review of vendor CoA's, data verification for internal CoA's and regulatory filings Review of Analytical test methods, transfer protocols, qualification protocols and associated reports. Keeps abreast of current regulatory and industry guidelines to support the on-going clinical development and to ensure compliance across multiple regulatory jurisdictions. Work closely with contract service provider (CSP) Quality Control testing groups to support assay troubleshooting where needed. Full understanding of selection, characterization, and maintenance of Reference Standard Program. Including generation of protocols, data review and statistical analysis of data generated. Responsible for generating the reports associated with the program. Draft technical reports to summarize development and assay qualification studies. Can work in a team environment but can also take ownership of large technical reports and projects. Qualifications MS/BS/BA within Biology, Biochemistry, Cell Biology, or related field (Cell Biology, Biology or Biochemistry preferred) and 4 to 8 years' experience required GxP experience in a Quality Control or Analytical Development laboratory with experience or first-hand knowledge in analytical method development and qualification under ICH/FDA guidelines is required. Experience working under global regulatory agencies such as the EMA and HC is highly desirable. Mastery of the Microsoft Office Suite (Word, Excel, PowerPoint) required Strong written and verbal communications skills required Experience working with electronic quality management systems is desired. Willingness to take on new and unfamiliar tasks. Must be able to navigate in a fast-paced environment and have the ability to prioritize multiple objectives appropriately Benefits Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and 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. PId54a1de2b30b-8761

Description: The Company: Larimar Therapeutics Inc. 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 (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. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Director to lead all aspects of Trial Master File (TMF) management across all studies. This role will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management and inspection experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities Trial Master File (TMF) Management Accountable for the company's TMF processes and systems, serving as the business process owner and the system owner for the eTMF. Develop and implement global standards, standard operating procedures, and corresponding controlled documents that are in line with ICH-GCP and all relevant regulatory requirements (e.g., EMA, FDA, MHRA) and industry best practices (e.g., CDISC), including the maintenance and update of the TMF index as changes occur to Larimar and/or vendor SOPs. Develop and implement TMF strategy within Larimar and identify, hire, oversee resources and/or vendors supporting the TMF/eTMF and TMF-related initiatives. Management of the company's eTMF system and support the implementation and integration of any systems or processes that would interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS), etc.), including data mapping between systems, configuring standard processes and workflows across systems, and managing integrations on an ongoing basis as business needs evolve Establishing governance structure and leading governance meetings with vendors including those supporting clinical studies (e.g., clinical CRO, data management provider) and any vendors supporting the TMF/eTMF including technology providers. Responsible for ensuring that the eTMF system remains in a validated state, and complies with all computer systems validations (CSV) regulations including Annex 11/Part 11 and GAMP. Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts. Providing study support to cross-functional teams on TMF regulations, processes, and best practices, and supporting document management needs on studies including the development and review of study plans and documents. Supporting internal and external audits and inspections, may include but is not limited to: developing training materials and administering training to inspectors, managing inspector access, supporting teams with document retrieval during audit/inspection, providing system-related support, answering questions around the eTMF system and/or eTMF system procedures, and providing demos or guided-support for the eTMF system, as requested. Clinical/GCP Inspection Readiness As a core member of the inspection readiness team, lead inspection readiness (IR) efforts across clinical study teams and work with cross-functional stakeholders to identify and ensure completion of inspection readiness activities and deliverables within associated project timelines. Contribute to the inspection readiness project deliverables, timelines, and resources. Organize inspection readiness meetings with the relevant study team members, the extended inspection team, and function-specific team IR meetings Contribute to the Development and implementation of tools and templates for the management of inspection readiness activities, including for example, FDA BIMO checklists, project plans, timelines, training materials, study-specific tracking tools (e.g., issue management logs, study document and plan tracking, vendor lists, IT computer systems lists, etc.) Supporting study teams with the execution of IR tasks, as needed. Assist with identifying study issues and working with the clinical study team and Quality to develop CAPAs and strategies to mitigate risks. Supporting study team members with the creation and management of storyboards, NTFs, and project-related documentation, as needed. Supporting gap assessments of clinical procedures and participating in the development and review of clinical SOPs Support the clinical team on all inspection commitments, responses, post-inspection activities and the implementation of corrective and preventative actions. Working with quality and the inspection readiness lead in the development of Laminar onsite and remote inspection management procedures and logistics. Hiring, management, and/or oversight of resources including employees, contractors, consultants, vendors Leading and conducting other projects/tasks as needed to support Larimar inspection readiness activities. Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor/MS degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Experience with health authority inspections at the Sponsor level in both front and backroom Strong, practical knowledge of the CDISC TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Experience managing direct reports Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and 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. PI94415ea9884f-1581