Manager, Global Regulatory Operations

Disc Medicine

Regulatory Operations Manager at clinical-stage biopharmaceutical company managing document compliance and submissions. Detail-oriented role ensuring regulatory standards in a hybrid work environment.

Posted 5/2/2026full-timeWatertown • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $128,000 - $156,000 per yearWebsite

About the role

Key responsibilities & impact

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.
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.
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

What you’ll need

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.

Benefits

Comp & perks

Comprehensive benefits
Competitive compensation packages
Flexible work environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

document compliancedocument publishingsubmission readinessmetadata auditsclinical study reporteCTD reviewVeeva RIM submissionsmulti-document publishingregulatory submissionsSOPs authoring

Soft Skills

attention to detailorganizational skillseffective communicationinterpersonal skillsself-motivatedflexibilityintegritygood judgmentdecision-makingcollaborative

Certifications

high school diplomaAssociate’s Degree