Senior Manager, Global Regulatory Submission Management and Publishing (Veeva Vault RIM)

Location: Woburn, United States; remote work is available with an expectation of approximately 10% onsite attendance for company-wide meetings and key business events.

Salary: $137,500–$168,500 annual base pay, plus performance incentive bonus, new hire equity, and ongoing performance-based equity.

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies through its proprietary RPx platform to transform cancer treatment.

What you will do

• Lead the planning, coordination, preparation, publishing, validation, transmission, and archiving of global regulatory dossiers.
• Manage submission timelines, deliverables, risks, milestones, and communications with internal stakeholders and external service providers.
• Publish and transmit INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, annual reports, and other regulatory filings.
• Serve as a subject matter expert for Veeva Vault RIM Submissions and Publishing, including dossier planning, content planning, assembly, continuous publishing, and validation.
• Develop and improve regulatory publishing processes, standards, templates, and procedures while supporting inspection readiness and audit responses.
• Provide technical leadership, mentoring, training, and guidance to regulatory publishing and submission management team members.

Requirements

• Bachelor's degree or equivalent combination of education and relevant experience.
• At least 8 years of Regulatory Operations and Regulatory Publishing experience in biotechnology, pharmaceuticals, or a related industry.
• Experience leading complex global regulatory submissions from planning through delivery, including INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, and annual reports.
• Expert-level knowledge and hands-on experience with Veeva Vault RIM Submissions and Publishing.
• Strong knowledge of FDA, EMA, MHRA, ICH, and other global regulatory requirements, as well as eCTD and CTIS standards.
• Experience with SEND datasets, regulatory submission datasets, publishing tools, project management, stakeholder management, and quality control.

Nice to have

• Experience with StartingPoint tools and templates.
• Experience with Veeva PromoMats.
• Experience with DXC, eCTD Xpress, ISI Toolbox, Lorenz, or equivalent regulatory publishing platforms.

Culture & Benefits

• Collaborative, bold, dedicated, and candid working environment.
• Remote work with limited onsite attendance for key events.
• Medical, dental, and vision insurance.
• 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
• Competitive total rewards program with incentive and equity opportunities.