Senior Manager, Regulatory Operations

Parabilis Medicines

Regulatory Operations leader advancing Parabilis Medicines’ clinical-stage biopharmaceutical submissions. Leading Veeva RIM, eCTD publishing, regulatory technology, and compliant processes.

Posted 8/21/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $145,000 - $175,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Regulatory Operations with a focus on global regulatory submissions, eCTD publishing, and regulatory information management. Proven ability to lead cross-functional teams and implement technology solutions to enhance operational efficiency.

Highest-signal resume keywords

Regulatory Operations ExperienceECTD PublishingVeeva Vault RIMFDA Electronic SubmissionsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Information ManagementDocument Lifecycle ManagementRegulatory SubmissionsSOP DevelopmentInspection-Ready DocumentationGlobal SubmissionsCTAsHealth Authority InteractionsAI Tools UtilizationTraining End Users

Soft Skills

Communication SkillsCollaboration SkillsOrganizational SkillsLeadership SkillsProject Management Skills

Tools & Technologies

Veeva RIM BasicsRegulatory Information Management SystemsAI Tools

Industry Keywords

BiotechnologyPharmaceutical IndustryRegulatory AffairsClinical DevelopmentQuality

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Provide operational leadership supporting global regulatory submissions from planning through archival
Serve as the business lead for Regulatory Information Management and Veeva RIM Basics
Partner with cross-functional stakeholders to implement standardized document lifecycle management
Support the transition to an internal Regulatory Operations publishing model
Develop and maintain inspection-ready regulatory information supporting U.S. and global regulatory submissions
Partner with the Director of Regulatory Operations to modernize Regulatory Operations through technology and automation
Partner closely with Regulatory Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality, compliant, and timely regulatory submissions

Requirements

What you’ll need

Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience
Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry
Extensive experience supporting FDA electronic submissions
Strong knowledge of eCTD publishing and submission lifecycle management
Experience with Veeva Vault RIM or Veeva RIM Basics
Experience supporting regulatory information management systems
Experience supporting global submissions, including CTAs and Health Authority interactions
Experience training end users on regulatory systems
Experience developing Regulatory Operations processes and SOPs
Strong project management and organizational skills
Excellent communication and collaboration skills
Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus
Able to attend in-person meetings

Benefits

Comp & perks

Annual target bonus
Equity
Comprehensive suite of competitive benefits designed to support employees’ overall well-being