Senior Specialist, Regulatory Operations

TL;DR

Senior Specialist, Regulatory Operations: Managing end-to-end regulatory submissions across the development pipeline and supporting the commercial portfolio with an accent on eCTD submission readiness, regulatory document management, and regulatory technology operations. Focus on hands-on submission management, vendor and internal stakeholder oversight, and improving submission efficiency through processes, templates, and tools.

Location: Frederick, MD

Salary: $70,000 - $130,000 USD

Company

Fully integrated, commercial-stage biotechnology company focused on CNS and immunology treatments.

What you will do

• Lead end-to-end management of regulatory submissions to ensure timely, compliant, high-quality deliverables.
• Serve as submission manager and primary contact for publishing vendors and internal stakeholders for eCTD submission activities.
• Oversee regulatory document management, tracking, and archival activities.
• Manage regulatory systems (e.g., Veeva RIM, PromoMats) and act as an internal SME for training and support.
• Develop and implement processes, templates, and tools to improve submission efficiency and consistency.
• Partner with IT to maintain the regulatory technology landscape (maintenance, updates, releases) and monitor regulatory/industry changes.

Requirements

• 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 PromoMats (strongly preferred).
• Ability to travel 10% of the time.
• Bachelor’s degree in a scientific or related field.

Culture & Benefits

• Medical, dental, and vision insurance; life and AD&D insurance; short- and long-term disability.
• Flexible Spending Accounts and Health Savings Account.
• 401k with company match and annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Career development and training; employee assistance programs.

Hiring process

• Interviews with Regulatory Affairs and cross-functional stakeholders to assess submission operations experience and regulatory technology fit.
• Evaluation of hands-on experience with eCTD submissions and regulatory systems.