Associate Director, Regulatory Operations, EMEA

Location: Basel, Switzerland. Hybrid work model with onsite presence typically required 2–3 days per week, or more depending on business needs.

Company

hirify.global is a biotechnology company developing innovative treatments for rare diseases and advancing regulatory and clinical care models.

What you will do

• Lead end-to-end planning and execution of complex regulatory submissions across EMEA, coordinating Regulatory Affairs, Global Regulatory Operations, project management, stakeholders, and vendors.
• Develop submission publishing strategies, timelines, milestones, content plans, and delivery plans while managing risks, dependencies, resources, and critical-path activities.
• Perform or oversee document preparation, compilation, bookmarking, hyperlinking, metadata verification, technical quality control, validation, and electronic submission transmission.
• Ensure regulatory documentation, data, and submission activities are accurate, complete, inspection-ready, and aligned with regional and local requirements.
• Build cross-functional alignment and drive process improvements, change management, training, digital enablement, and scalable solutions.
• Monitor evolving regulatory requirements and industry initiatives, including eCTD 4.0, IDMP/SPOR, structured content, metadata governance, and next-generation submission models.

Requirements

• Bachelor’s degree in a scientific, technical, or related discipline, or equivalent relevant experience.
• At least 8 years of Regulatory Operations experience in the pharmaceutical, biotechnology, or related life sciences industry.
• Extensive knowledge of global regulatory submission requirements, formats, standards, processes, and health authority expectations.
• Experience operating as both a Submission Manager and Publisher on complex global regulatory submissions.
• Strong communication, stakeholder engagement, project leadership, problem-solving, quality, and compliance skills.
• Working knowledge of EMA submission and data portals, Veeva Vault RIM, Lorenz DocuBridge, StartingPoint Templates, DXC Toolbox, Adobe Acrobat Professional, SharePoint, Smartsheet, AI-enabled solutions, or comparable tools.

Nice to have

• Experience with eCTD 4.0 submissions, pilot programs, testing, implementation, or transition planning.
• Leadership experience in process improvement, business transformation, digital enablement, or technology implementation.
• Experience working in a fast-changing, agile small-company environment.

Culture & Benefits

• Supportive and inclusive environment focused on learning and professional growth.
• Vacation time and company-observed public holidays.
• Volunteer days, wellbeing benefits, and fitness reimbursement.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Tuition sponsorship and professional development plans, with benefits varying by region and country.