Regional Submission Planner Senior SpecialistVerified as a real position

Who we’re looking for

• Bachelor’s degree in a Life Science, Pharmacy or Engineering related discipline.
• At least 4 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs. Regulatory operations experience is preferred.
• Strong written and oral communication skills in English.

What you’ll do

• Lead the planning, coordination and review of complex regional regulatory submissions, ensuring compliance with internal and external requirements for timely delivery to the Health Authorities.
• Develop and maintain regulatory submission plans for the assigned programs/products ensuring strategic alignment with milestones and deadlines.
• Drive, facilitate and actively contribute to cross-functional meetings to ensure effective planning, execution and communication of regulatory submission activities.
• Drive the submission assembly and delivery process in collaboration with the Submission Publisher ensuring all submissions meet quality and timelines expectations.
• Manage and maintain regulatory systems and databases to support submission tracking, reporting and compliance requirements.
• Proactively identify, lead and implement process improvements to drive efficiencies and enhance submissions related activities. Participate in process improvement projects.
• Maintain a robust understanding of regulatory requirements, leveraging this knowledge to support the planning and execution of submissions across regions.
• Collaborate with internal and external stakeholders to ensure alignment and successful execution of submission deliverables.
• Serve as a key contributor in cross-regional initiatives or projects.
• Support strategic initiatives related to the submissions process such as technology enhancements and process optimization.
• Maintain up-to-date knowledge of regulatory processes and evolving requirements within EU + EEMEA and other regions, as applicable.

About the position

The Senior Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations department (RRO), supporting regional planning activities for the EU + EEMEA region while also contributing to cross-regional planning activities as needed. The Regional Submission Planner will support the regulatory submission plan creation and registration tracking of the company’s regulatory submission targets from a regional and cross-regional operational perspective.

Benefits

• Exciting work in a great team, global projects, international environment
• Opportunity to learn and grow professionally within the company globally
• Hybrid working model, flexible role pattern
• Pension and health insurance contributions
• Internal reward system plus referral program
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
• Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card
• Vodafone, Raiffeisen Bank, Foodora, and other discount programs
• Up-to-date laptop and iPhone
• Parking in the garage for drivers or showers for bikers
• Competitive salary, incentive pay, and many more