Regional Submissions Planner

About the role

The Regional Submissions Planner works within the Global Regulatory Affairs and Clinical Safety organization, supporting planning and execution of regulatory submissions for the EU + EEMEA region. The role coordinates submission plans, tracks registrations, and ensures high‑quality, timely delivery to health authorities while collaborating with cross‑functional teams.

Key responsibilities

• Plan, coordinate and review regional regulatory submissions to meet internal and external deadlines.
• Develop and maintain submission plans aligned with program milestones.
• Facilitate cross‑functional meetings to ensure smooth execution of submission activities.
• Drive the assembly and delivery of submissions in collaboration with the Submission Publisher.
• Manage regulatory systems and databases for tracking, reporting and compliance.
• Identify and implement process improvements to increase efficiency.
• Support cross‑regional initiatives and strategic technology enhancements.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy or Engineering.
• Minimum 2 years experience in pharmaceutical operational roles, project management or regulatory affairs.
• Strong written and oral communication skills in English.
• Ability to work effectively in multicultural, cross‑functional environments.

Required skills

• Electronic Common Technical Document (eCTD)
• Regulatory Affairs Management
• Procedure Development
• Project Planning
• Regulatory Submissions
• Regulatory Compliance

What we offer

• Hybrid working model with flexible patterns.
• Competitive salary and incentive pay.
• Pension and health insurance contributions.
• 5 weeks annual leave plus additional sick and parental benefits.
• Cafeteria benefits, Multisport Card, discount programs.
• Up‑to‑date laptop and iPhone, parking or bike showers.