Director, Regulatory Affairs

About Us:

We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases. At Larimar, we embrace everyone’s contribution to our Mission. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate. If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!

We are a 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, 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 and about 40 employees. Our 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). 

Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team’s know how and expertise to the development of CTI-1601 and other future pipeline programs. 

Position Summary:

Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and regulatory activities for products in development specific to European regions and assistance with other global regions. The Director will be a key member of project teams. The role reports to the Senior Director of Regulatory Affairs.

Job Duties/Responsibilities:

  • Define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects
  • Be a key contributing member of project teams to lead regulatory aspects of projects related to global clinical trials, health authority interactions and product submissions and approval
  • Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development submissions and approvals, while ensuring compliance with applicable global regulatory requirements
  • Manage the regulatory aspects, as assigned, of projects including the preparation and submission of INDs/CTAs, amendments, correspondence, meeting applications to regulatory agencies, and regulatory marketing authorization applications, including but not limited to EMA, MHRA and other local European agencies
  • Lead regulatory submissions to global health authorities to ensure high-quality, timely submissions that align with Larimar’s regulatory strategy and plan
  • Prepare Larimar assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings
  • Develop internal regulatory procedures and practices 
  • Serve as backup to other global region regulatory activity 

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 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 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
  • Can do attitude, flexibility, and mental agility

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.