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The Associate Director, Regulatory Affairs Operations leads the end-to-end execution of regulatory operational activities, ensuring the efficient, compliant, and timely delivery of global regulatory submissions. This role provides hands-on leadership and oversight of day-to-day operations across submissions, publishing, regulatory systems, SOPs, and vendor management, serving as a key partner to Regulatory Affairs and cross-functional stakeholders.

This position is critical to strengthening operational control, reducing risk, and alleviating execution bottlenecks by driving accountability for operational excellence. Through effective management of regulatory systems (e.g., Veeva, DocuBridge), publishing processes, and vendor performance, the Associate Director enables proactive issue resolution, early risk identification, and continuous process improvement.

Working in close partnership with the Senior Director of Regulatory Operations, this role allows for a clear separation of execution and strategy. The Associate Director ensures consistent, high-quality operational delivery, enabling the Senior Director to focus on enterprise strategy, capacity planning, and inspection readiness.

This is a hands-on leadership role requiring strong organizational capability, attention to detail, and the ability to manage complex regulatory deliverables in a fast-paced, evolving biotech environment.

Key Accountabilities:

• Regulatory Operations Leadership
  • Lead the planning, coordination, and execution of global regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring compliance with global regulatory requirements and timelines.
  • Provide operational oversight of eCTD submission activities, partnering with external publishing vendors and internal stakeholders to ensure high-quality, timely deliverables.
  • In partnership with the Senior Director of Regulatory Operations, play a key role in establishing internal publishing capabilities, including being a partner in defining and leading implementation of publishing capability strategy
  • Ensure accurate maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems.
• Process & System Management
  • Oversee regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and inspection readiness.
  • Serve as system administrator for regulatory systems (e.g., Veeva RIM) and act as the internal subject matter expert (SME), driving training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap.
  • Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements.
  • Drive the development and continuous improvement of regulatory operations processes, tools, and best practices to enhance efficiency, quality, and consistency.
• Team Leadership
  • Lead, mentor, and develop a small team of regulatory operations staff, fostering a high-performing and collaborative team environment.
  • Oversee vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness.
• Submission Strategy Support
  • Partner with Regulatory Affairs leads to operationalize global submission strategies.
  • Collaborate cross-functionally with clinical, quality, and CMC teams to ensure alignment and execution of submission plans.
  • Monitor submission milestones and deliverables, proactively identifying risks and driving mitigation strategies to prevent delays.
• Compliance & Quality
  • Ensure ongoing compliance with global regulatory standards and organizational policies.
  • Maintain inspection readiness and support internal and external audits.
  • Ensure integrity, accuracy, and completeness of regulatory records and documentation.
• Project Management
  • Manage submission timelines, milestones, and deliverables across programs.
  • Lead risk assessment, escalation, and resolution to ensure successful execution of regulatory activities.

Education and Experience:

• Bachelor's degree in Life Sciences or a related discipline is required.
• Minimum of 9 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry, including demonstrated leadership experience of at least 2 years.
• Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; experience with Veeva Vault Regulatory is required.
• Strong working knowledge of the drug development process and global regulatory frameworks.
• Experience managing with and/or overseeing external publishing service providers for regulatory submissions is desirable.
• Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams.
• Experience using project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to support regulatory timelines and deliverables.
• Strong Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.
• Expertise in eCTD publishing and lifecycle management
• Deep knowledge of global regulatory submission requirements (e.g., CTD/eCTD structure, format, and submission requirements, and proficiency in MS Word (e.g., authoring templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g., CSC Toolbox, Lorenz DocuBridge, or equivalent); advanced or expert-level knowledge is an advantage.
• Strong leadership, organizational, cross-functional communication, and project management skills, with the ability to manage multiple priorities simultaneously and assess the impact of changes on project timelines.
• Ability to work effectively in a collaborative, fast-paced, mid-size company environment.
• Fluency in English (spoken, written, and reading); proficiency in an additional European language is an asset.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills