Manager, Global Regulatory Operations

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.

Disc Medicine is seeking a detail-oriented and experienced Regulatory Operations Manager, reporting to the Head of Global Regulatory Operations. This full-time role will be instrumental in managing document compliance activities for regulatory submission documents, document publishing (e.g. IMPDs, meeting packages and CSRs), assisting with regulatory submission activities, performing Veeva RIM inputs, interacting with project team members and Regulatory vendors, authoring best practices and providing associated training as assigned, and other Regulatory Operations projects as needed.

• High school diploma or equivalent required; Associate’s Degree or above preferred.
• 5-7 years of direct experience. Level to commensurate with task and leadership experience.
• High knowledge of various document types (CMC, Nonclinical, Clinical, Regulatory) and submission readiness expectations.
• Expert MS Word, StartingPoint template, Adobe Acrobat Pro and Toolbox Pharma plug-in experience.
• Prior Clinical Study Report and multi-document publishing experience required.
• Proven ability to work independently with minimal to no supervision for document compliance and document publishing tasks.
• Intermediate to advanced work experience with Veeva RIM Submissions and Submissions Archive applications with knowledge of various RIM record metadata.
• Driven to meet deadlines with high attention to detail and quality.
• Proven ability to effectively multi-task and work under tight deadlines; must possess excellent organizational skills.
• Effective communication and interpersonal skills; must be self-motivated with eagerness to learn and desire to grow professionally.
• Personal attributes include: flexibility and integrity, good judgment and decision-making skills, action- and results-oriented, collaborative and team-oriented
• Occasional travel required, as needed.
• Prior experience with submission management and pre-publish compilation tasks for various IND submission types and subsequent post-publish eCTD review processes a plus.
• Prior UAT testing experience is highly desirable.