Director, Regulatory Affairs Operations

Job Summary:

The Director, Regulatory Affairs Operations is accountable for defining and executing the regulatory operations strategy for the organization. This role leads the operational infrastructure, processes, and systems that enable Regulatory Affairs to operate efficiently, compliantly, and at scale in a growing I&I biotechnology company. The Director ensures that global regulatory submissions are strategically planned, executed, tracked, and archived with precision. Responsibilities include the assessment, onboarding, oversight, and performance management of external regulatory operations vendors, as well as ownership of the regulatory operations budget, in close partnership with IT, Quality, and the direct manager. The role is responsible for optimizing the regulatory information management (RIM) ecosystem, establishing robust publishing and submission execution frameworks, and ensuring inspection‑ready archival and traceability across the submission lifecycle.

In addition, the Director develops and implements regulatory operations processes and training programs to support cross‑functional stakeholders, provides ongoing system and user support, and—working closely with Regulatory Leads—ensures cross‑functional alignment on regulatory timelines, milestones, and submission readiness. The Director partners extensively with enterprise functions including Regulatory Strategy, Clinical Development, Preclinical, Quality, Commercial, and IT to design and lead an end‑to‑end regulatory operations model. This includes defining how submissions are planned, authored, assembled, delivered, and maintained throughout their lifecycle. The role also leads the development of an enterprise regulatory data model that enables seamless data flow, reuse, and traceability across programs and regions. Through the establishment of a high‑performing vendor ecosystem and scalable operational backbone, the Director, Regulatory Affairs Operations builds the foundation for a world‑class regulatory function capable of supporting Beeline Medicines’ growth and global ambitions.

Work Arrangement & Location: 

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities:

• Define and lead the Regulatory Affairs Operations strategy, establishing scalable infrastructure, processes, and systems to enable efficient, compliant global Regulatory Affairs execution from IND through post‑approval.
• Own end‑to‑end submission planning and execution, ensuring regulatory submissions are planned, built, validated, delivered, tracked, and archived with precision, including eCTD lifecycle management and Health Authority interactions.
• Oversee the regulatory information management (RIM) ecosystem and enterprise regulatory data model, enabling seamless data flow, reuse, traceability, inspection readiness, and a complete, accessible, and user‑friendly regulatory archive.
• Establish and manage the regulatory submission and publishing operating framework, defining standards for content creation, management, reuse, quality review, and archival across the full submission lifecycle.
• Build and manage a high‑performing regulatory vendor ecosystem, defining outsourcing strategies, performing vendor assessment, onboarding, oversight, performance management. Oversights the regulatory operations budget ownership in partnership with IT, Quality, and leadership.
• Develop regulatory operations processes, training, and user support models, driving adoption, consistency, and effective use of systems and workflows across internal teams and external partners.
• Drive operational excellence and executive transparency, establishing KPIs, metrics, and risk management practices; conducting periodic quality assessments of the regulatory management system; and communicating submission readiness, risks, and operational insights to senior leadership.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Bachelor's degree in life sciences, pharmacy, or a related field required; advanced degree preferred.
• Minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotech industry
• With at least 3 years in a regulatory operations leadership role.
• Demonstrated experience managing eCTD submissions and electronic publishing processes, including familiarity with FDA, EMA, and ICH eCTD technical specifications.
• Hands-on experience with Regulatory Information Management (RIM) systems such as Veeva Vault Regulatory, PAREXEL's Liquent, InSight, EGNYTE or equivalent platforms.
• Thorough knowledge of ICH CTD requirements, FDA 21 CFR Part 11, and applicable regulatory submission standards across clinical development phases.
• Proven ability to manage complex submission timelines and cross-functional regulatory deliverables in a matrixed pharmaceutical or biotech environment.
• Experience developing regulatory SOPs, training materials, and governance frameworks in compliance with international regulatory requirements.
• Familiarity with Trial Master File (TMF) standards (DIA Reference Model) and inspection readiness practices.
• Strong regulatory project management skills; experience with regulatory-specific project management tools and timeline visualization platforms is preferred.
• Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
• Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.