[Hiring] Director, Regulatory Affairs Operations @Beeline Medicines

Role Description

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.

• Assessment, onboarding, oversight, and performance management of external regulatory operations vendors.
• Ownership of the regulatory operations budget, in close partnership with IT, Quality, and the direct manager.
• Optimizing the regulatory information management (RIM) ecosystem.
• Establishing robust publishing and submission execution frameworks.
• Ensuring inspection‑ready archival and traceability across the submission lifecycle.
• Developing and implementing regulatory operations processes and training programs to support cross‑functional stakeholders.
• Providing ongoing system and user support.
• Ensuring cross‑functional alignment on regulatory timelines, milestones, and submission readiness.
• Partnering extensively with enterprise functions including Regulatory Strategy, Clinical Development, Preclinical, Quality, Commercial, and IT.
• Leading the development of an enterprise regulatory data model that enables seamless data flow, reuse, and traceability across programs and regions.
• Building the foundation for a world‑class regulatory function capable of supporting Beeline Medicines’ growth and global ambitions.

Qualifications

• 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.
• 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.

Requirements

• 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.
• Oversight of 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.

Benefits

• Medical, Dental & Vision insurance (employee premiums 100% covered by company).
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge.
• Flexible work arrangements / hybrid schedule.
• Health Savings Account (HSA).