Manager, Global Regulatory Operations

POSITION OVERVIEW:

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.

RESPONSIBILITIES:

Regulatory Submission Quality & Publishing Operations (~50%)

• Perform submission readiness quality checks and updates on MS Word and PDF files per company style guide and health authority guidance.
• Execute report and multi-file publishing activities and manage related processes to meet regulatory standards.
• Manage Veeva RIM HA Questions, Meetings and Commitment databases
• Assist Regulatory Operations submission manager with Veeva RIM data entry and submission-related tasks (pre- and post-dispatch).
• Manage investigational maintenance submission tasks as resources allow or are prioritized by management, e.g. IND investigator submissions. Oversight to commensurate with experience.
• Assist submission team members with document uploads.

Regulatory Documentation Standards & Training (~30%)

• Create and manage document templates used for regulatory submissions.
• Manage StartingPoint training documentation and serve as SME to deliver training to regulatory document authors.
• Perform Veeva RIM metadata audits as assigned
• Review and/or author best practices, work instructions, and SOPs for regulatory operations tasks and present as requested.

Cross-Functional Collaboration & Process Improvement (~20%)

• Interact with functional document owners to communicate findings and negotiate resolution steps.
• Participate in Regulatory Operations process improvement and system initiatives
• Provide input for applications associated with the job function and participate in User Acceptance Testing (UAT) as requested.

 REQUIREMENTS:

• 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.