Director Regulatory Affairs-CMC

3 weeks ago

Oklahoma City, United States Disc Medicine Full time

Disc Medicine is seeking a Director, Regulatory Affairs-CMC to serve as the Regulatory-CMC lead for Disc Medicine’s small molecule program pipeline. This position will have close collaboration with the development teams and visibility to the executive leadership with meaningful opportunities for professional development and career growth.The position reports to the Senior Director, Regulatory Affairs-CMC. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. RESPONSIBILITIES: Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for Disc’s small molecule pipeline. Represent regulatory-CMC on cross-functional project and technical teams. Develop regulatory-CMC strategies based on regulatory and technical experience, provide guidance to teams on current phase-appropriate regulatory expectations, pro‑actively identify opportunities and risks, and work with teams to develop mitigations. Lead regulatory-CMC discussions with regulatory authorities and preparatory activities (e.g., responses to information requests, requests for advice). Prepare and manage regulatory-CMC submissions with phase-appropriate regulatory‑CMC strategies, ensuring on-time, high-quality, and accurate submissions aligned with company strategies and Health Authority requirements. Review and provide regulatory assessments on change controls. Ensure Disc’s compliance with regulatory requirements and Disc Medicine’s internal Standard Operating Procedures (SOPs). Ensure regulatory-CMC conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es). Interpret and assess impact of new regulations; identify potential opportunities/risks and coordinate with internal stakeholders to develop strategies to address any potential changes. Support departmental objectives including the development of business processes, procedures, and/or templates to guide regulatory-CMC development. REQUIREMENTS: BA/BS required, Ph.D. or other graduate degree preferred. A minimum of 10 years of total pharmaceutical/related industry experience.A minimum of 8 years regulatory CMC experience. The ideal candidate would have a strong background in regulatory affairs-CMC with expertise in small molecules/solid oral dosage forms, a deep familiarity with product development requirements particularly in late-stage development/NDA preparation and a strong understanding of global regulatory (FDA, EMA, PMDA, etc.) requirements and ICH guidelines. Extensive experience in preparing quality sections of regulatory filings including Health Authority briefing packages, IND/IMPDs, and NDA/MAAs. Strong technical background to allow understanding of technical aspects of manufacturing and analytical topics, and authoring of technical regulatory filings in collaboration with subject matter experts. Experience working on project teams. Strong interpersonal skills and the ability to collaborate effectively with cross-functional representatives from manufacturing, analytical, quality assurance, program management, etc. Proven ability to manage projects with cross-functional teams. Excellent written and communication skills with attention to detail. Highly computer literate (Microsoft Word, PowerPoint), including document formatting for submissions. Familiarity with document management systems/regulatory information management systems is a plus. The candidate should be a self-driven individual with strong organizational and communication skills as well as an ability to build effective working relationships. Have and maintain in-depth knowledge and understanding of applicable US/EU regulations on the CMC development for small molecules.Assess impact of new regulations, manage regulatory-CMC documents, etc. Remote with availability during East coast working hours. Some travel expected (~10%)

Disc Medicine is an equal opportunity employer committed to providing all qualified candidates and employees equal opportunities.We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to our Human Resources Department atcareers@discmedicine.com and include the title of the position you are applying for in the subject line. Please note that agency phone calls or submissions will not be accepted. * * * More Jobs

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