Manager Regulatory Affairs Operations (Boston)
Work for an Organization that brings innovative therapies to patients worldwide.
VectorY combines the therapeutic potential of antibodies combined with AAV based delivery to develop long-lasting therapeutic solutions for neurodegenerative diseases of high unmet medical need.
Founded in August 2020, and based in the Amsterdam Science Park, VectorY is a fully integrated precision medicines company focused on the development of innovative vectorized antibody therapies for the treatment of neurodegenerative diseases such as ALS and Huntington’s disease.
The company has established a strong foundation for future growth having raised 160m euros in 2 financing rounds including a 129m euro series A round in November 2023 supported by a strong investor syndicate.
Short description of the role
This role supports global regulatory activities across VectorY’s development programs, with primary responsibility for regulatory submission planning, execution, publishing, and lifecycle management. The Manager owns the Regulatory Operations infrastructure, including regulatory systems, electronic submission platforms, document and submission management processes, and overall Regulatory Information Management (RIM) needs.
The role is hands‑on and execution‑focused, partnering closely with Regulatory Affairs leadership and cross‑functional teams to deliver high‑quality, timely, and compliant global submissions. The Manager serves as the primary owner of submission infrastructure, leading the implementation and day‑to‑day use of the RIM system, eCTD publishing tools, and electronic submission gateways to ensure efficient and inspection‑ready regulatory operations.
Location: Boston, MA or Remote (US – East Coast)
Main responsibilities of the role:
Lead the planning, execution, publishing, and lifecycle management of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, annual reports, and regulatory correspondence, ensuring high‑quality, on‑time delivery.
Design, implement, and maintain scalable regulatory operations infrastructure, including eCTD publishing platforms, Regulatory Information Management (RIM) systems, and internal submission workflows, in compliance with company SOPs and global regulatory requirements.
Serve as the technical lead for electronic submission standards, ensuring ongoing compliance with evolving regulatory agency specifications (e.g., FDA, EMA, ICH, eCTD).
Establish and maintain secure, reliable submission pathways and connection protocols for regulatory gateways and portals (e.g., FDA ESG, NextGen, EMA eSubmission Gateway).
Manage end‑to‑end submission activities, including document publishing, submission planning, document readiness, technical validation, quality control, electronic transmission, archiving, and inspection‑ready record‑keeping.
Maintain integrated submission plans, trackers, and timelines aligned with program regulatory strategies and development milestones; proactively identify risks and coordinate mitigation actions.
Coordinate document readiness across functions, including content finalization, quality control, publishing, sequencing, and submission logistics.
Support regulatory lifecycle activities such as protocol amendments, Investigator’s Brochure updates, safety‑related submissions, post‑approval submissions, and annual reporting.
Partner closely with Regulatory Affairs leadership to translate regulatory strategy into operational execution plans.
Collaborate cross‑functionally with Clinical, CMC, Nonclinical, Safety, and external partners to align deliverables and resolve submission issues.
Support operational aspects of regulatory agency interactions, including briefing document planning, submission logistics, and tracking of agency feedback and post‑submission commitments.
Oversee and manage external vendors and contractors supporting regulatory publishing, systems, and technology initiatives.
Contribute to the continuous improvement and standardization of regulatory operations processes, tools, templates, and best practices to improve efficiency, consistency, and inspection readiness.
Support onboarding, training, and mentoring of internal team members and cross‑functional stakeholders on regulatory submission processes, systems, and publishing standards.
Skills and Qualifications:
Bachelor’s degree in Life Sciences or a related discipline.
5+ years of experience in Regulatory Affairs and/or Regulatory Operations within the pharmaceutical or biotechnology industry.
Working knowledge of the drug development process and global regulatory frameworks.
Experience supporting global regulatory submissions, including FDA and EMA submissions.
Familiarity with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic submission tools;
Strong organizational and project management skills, with the ability to manage multiple priorities in a fast‑paced environment.
Excellent written and verbal communication skills, with attention to detail and clarity.
Experience coordinating with or overseeing external publishing vendors is preferred.
Experience establishing, validating, and maintaining regulatory publishing, submission, and archival systems in compliance with global regulatory requirements is preferred.
Proficiency with project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) is preferred.
Experience in a clinical‑stage or fast‑growing, global biotech environment is preferred.
Your Natural Strengths and Drivers:
Moves fast and takes ownership—drives work forward with urgency and follow-through.
Thinks creatively and challenges assumptions
Collaborative and engaging mindset.
Thrives in a fast-changing environment. Adapts quickly, resets priorities, and hits deadlines.
Working at VectorY
We offer a personal and authentic experience within a young, ambitious biotech company with an established and strong infrastructure on the path to bring innovative therapies to patients worldwide.
Interested? Please apply and send your resume before 31 May 2026 to talent.acquisition@vectorytx.com for the attention of Sandra Lemmens.