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Director, Regulatory Affairs, CMC and Clinical

Company: Larimar Therapeutics
Location: Bala Cynwyd
Posted on: April 3, 2024

Job Description:

Description: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 Regulatory Affairs Director that will develop and support the global regulatory strategy and activities within the CMC area, and other RA areas as needed, for products in various stages of development. The Regulatory Affairs Director will serve as a key member on internal and external project teams. The role reports to the Regulatory Affairs Senior Director.Job Duties/Responsibilities:

  • Perform as a key member on internal and external project teams and serve as the regulatory point of contact to facilitate CMC regulatory development as it relates to global clinical trials, global health authority interactions and global product submissions and approvals.
  • Define, develop and lead CMC regulatory strategies that balance regulatory risk and speed to market approaches to maximize global regulatory success of Larimar development program objectives for its current and expanding pipeline.
  • Provide strategic and tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development submissions and approval, while ensuring compliance with applicable global regulatory requirements specific to CMC regulatory aspects.
  • Lead the authorship of CMC regulatory submissions to global health authorities that are high-quality and timely in alignment with Larimar's regulatory strategy and plan. Global regulatory submissions include but are not limited to original IND/CTA, amendments, Health Authority meetings, and marketing authorizations for US, EU/UK and other areas as identified.
  • 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, and rare disease product approvals on CMC and clinical regulatory topics.
  • Assist with the development of internal regulatory procedures and practices.
  • Works closely with Regulatory Affairs Sr. Director and may lead activities in other RA areas as needed. Additionally, will serve as backup for global region regulatory activity. Requirements:Key Experience, Skills and Knowledge:
    • Minimum of 4-year undergraduate degree
    • 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry (preference will be given to candidates with biologics and drug-device combination experiences)
    • Relevant technical experience within the (Bio-) Pharmaceutical Industry could be partially substituted for Regulatory experience.
    • Experience with CMC regulatory, Clinical regulatory and global Health Authority submissions and interactions preferred
    • Understanding of GxP systems and Quality principles
    • Ability to research global regulatory guidance (CMC, clinical and nonclinical) 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
    • Ability to adapt to changing priorities and objectives in a fast paced environment. 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.PI90693b470814-31181-33254397

Keywords: Larimar Therapeutics, Philadelphia , Director, Regulatory Affairs, CMC and Clinical, Executive , Bala Cynwyd, Pennsylvania

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