Director, Regulatory Affairs Operations

Pretzel Therapeutics is a biotechnology company headquartered in Boston, Massachusetts, with research facilities in Mölndal at GoCo House, part of GoCo Health Innovation City. Pretzel Therapeutics is dedicated to developing life-changing medicines with a broad pipeline of first-in-class treatments addressing novel targets within the mitochondria. By harnessing cellular energetics to modulate disease processes and improve survival, function and quality of life, we are ushering in a new treatment paradigm for a breadth of conditions spanning neurological, muscle, metabolic and rare diseases.

POSITION SUMMARY

The Director, Regulatory Affairs Operations will initially serve as the Company’s dedicated Regulatory Operations lead, functioning as an N-of-1 to establish the foundational systems, processes, governance, and execution model for regulatory operations at Pretzel Therapeutics.
This role is responsible for leading the implementation, integration, governance, and ongoing management of the Company’s Regulatory Information Management (RIM) platform while ensuring efficient execution of global regulatory submissions and lifecycle activities. As organizational needs evolve, the Director will be expected to build and scale a high-performing Regulatory Operations function, including future internal team members and external partners, to support a growing development and commercial portfolio.

KEY RESPONSIBILITIES

• Serve as the business owner and strategic lead for the implementation, integration, and ongoing management of the organization’s Regulatory Information Management (RIM) platform
• Lead cross-functional RIM deployment activities, including business requirements development, process mapping, system configuration, data migration, validation, user acceptance testing, training, and change management
• Establish and maintain regulatory data governance frameworks to ensure the integrity, accuracy, consistency, and traceability of regulatory information across the product lifecycle
• Partner with Information Technology, Quality, Clinical Development, CMC, and Regulatory Affairs stakeholders to integrate the RIM platform with applicable enterprise systems
• Develop and execute a multi-year RIM roadmap aligned with organizational growth and regulatory business needs
• Lead regulatory submission planning, coordination, publishing, and dispatch activities for global regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, amendments, annual reports, meeting packages, health authority responses, and other lifecycle activities
• Ensure submissions comply with applicable global regulatory requirements and electronic submission standards, including eCTD requirements
• Develop and maintain submission schedules, resource plans, regulatory trackers, operational dashboards, and performance metrics
• Establish, maintain, and continuously improve SOPs, work instructions, templates, and governance processes supporting regulatory operations
• Drive inspection readiness and ensure regulatory records are maintained in compliance with applicable regulatory requirements
• Identify opportunities for automation, workflow optimization, and operational efficiencies across Regulatory Affairs
• Initially serve as the primary Regulatory Operations owner, while establishing the operating model, vendor support structure, and scalable foundation required to build a broader Regulatory Operations team over time
• Provide strategic operational guidance for major regulatory milestones, identify risks to regulatory timelines, and develop proactive mitigation plans

KNOWLEDGE AND SKILLS

• Deep knowledge of regulatory operations, global submission processes, electronic publishing standards, and regulatory lifecycle management
• Demonstrated experience leading Regulatory Information Management (RIM) system implementation, governance, optimization, training, and adoption
• Strong understanding of eCTD requirements, submission publishing, document management, validation, regulatory data management, and inspection readiness expectations
• Proven ability to lead complex cross-functional projects and enterprise system implementations in a biotechnology or pharmaceutical environment
• Excellent communication, stakeholder management, organizational, and influencing skills
• Ability to establish scalable processes, drive operational excellence, and build effective partnerships across Regulatory Strategy, Clinical Development, CMC, Quality Assurance, Medical Writing, Program Management, and Information Technology
• Commitment to collaboration, accountability, innovation, continuous improvement, and team development

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline; advanced degree preferred
• Minimum of 10-12 years of experience in Regulatory Affairs and/or Regulatory Operations within the biotechnology, pharmaceutical, or related industry
• Demonstrated experience leading the implementation and management of a Regulatory Information Management (RIM) system
• Extensive experience managing global electronic regulatory submissions and regulatory operations processes
• Experience supporting both development-stage and commercial products preferred

BENEFITS

Pretzel offers a highly competitive compensation package, including base salary, annual bonus eligibility, incentive stock options, comprehensive health, dental, and vision coverage, 401(k), paid time off, company holidays, and an annual winter shutdown.