Job Description

The Specialist Regional Submissions Planner will work within the 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.

This role works closely with various stakeholders to drive the identification, planning, execution, and management of activities to deliver high quality and timely regulatory and safety submissions for approval. The incumbent is expected to demonstrate strong project management skills with the ability to operate in a multicultural environment and experience working in a cross-functional setting.  Should be capable of independent management of all submission plans and documentation, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent may be involved in supporting internal or external process improvement or strategic initiatives.

Core Responsibilities:

• Plan, coordinate and review 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 alignment with milestones and deadlines.
• Facilitate and participate in cross-functional meetings to ensure smooth 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 needs.
• Continuously identify and implement process improvements to enhance efficiency and streamline submission 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.
• Support cross-regional activities by participating in initiatives or projects that involve multiple regions.
• Support strategic initiatives related to the submissions process such as technology enhancements and process optimization.
• Maintain knowledge of regulatory processes within EU + EEMEA and other regions as needed.

Qualifications:

• Bachelor’s degree in a Life Science, Pharmacy or Engineering related discipline.
• At least 2 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.
• Strong written and oral communication skills in English.

Desired Skills:

• Effective problem solving and critical thinking with ability to analyze, strategize, and find creative solutions to navigate complex regulatory landscapes and make informed decisions.
• Adaptable with the ability to adjust, modify, or change one's approach, behavior, mindset and/or plan in response to evolving priorities.
• Ability to collaborate, interact, and negotiate effectively with internal and external stakeholders in cross-functional and multicultural environments.
• Ability to communicate effectively, both verbally and in writing across levels and functional areas within the organization.
• Strong time management and detail orientation to support submissions planning and execution of projects/programs. 
• Team facilitation skills with the ability to establish collaborative environments and drive alignment across deliverables.
• Working knowledge of regulatory guidelines, procedures and processes, especially within the EU + EEMEA region.
• Ability to maintain oversight in the coordination and execution of planning, tracking, assembling, and delivering regulatory components in alignment with regulatory strategy and compliance.
• Experience in project management methodologies with the ability to handle multiple tasks and prioritize effectively.
• Familiarity with complex regulatory IT systems.

What we offer:

• 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

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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