Senior Specialist, Regulatory Operations

Role Summary

The Senior Specialist, Regulatory Operations will oversee submission management across the development pipeline and support the commercial portfolio. This hands-on role will assist with regulatory affairs systems, applications, and tools, including system implementations, maintenance, updates, and releases. The position reports to the Senior Director of Regulatory Affairs and can be based in an office or remote.

• Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables.
• Interface with external publishing vendors for the preparation of submissions and with internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
• Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
• Oversee regulatory document management, tracking, and archival activities.
• Manage regulatory systems (e.g., Veeva RIM, Promo Mats) and serve as internal subject matter expert (SME) for training and support to internal stakeholders.
• Develop and implement processes, templates, and tools that improve submission efficiency and consistency.
• Partner with IT to maintain the regulatory technology landscape, including maintenance, updates, and releases.
• Provide subject matter expertise on regulatory technologies and submission best practices.
• Monitor new regulations and industry trends to assess impact on operational practices.
• Any other supporting activities or research, as needed, for the regulatory team.

• 3-4 years of regulatory operations experience in biotech or pharmaceutical industry.
• Strong understanding of eCTD submission standards and regulatory requirements across global regions.
• Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
• Hands-on experience with Veeva RIM and/or Promo Mats strongly preferred.
• Bachelor's degree in a scientific or related field.
• Ability to travel 10% of the time.

• Experience managing outsourced publishing vendors is a plus.
• Ability to balance strategic oversight with hands-on execution.
• Strong communicator and collaborator with excellent organizational skills.

• Bachelor's degree in a scientific or related field.

• Travel up to 10% of the time.
• None specified beyond the above.