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.
Strong problem solving and critical thinking skills with the ability to analyze complex scenarios, design strategic solutions to navigate complex regulatory landscapes and drive informed decision making in dynamic-regulatory settings.
Adaptable with the ability to adjust, modify, or change one's approach, behavior, mindset and/or plan in response to evolving priorities.
Advanced ability to collaborate, interact, and negotiate effectively with internal and external stakeholders fostering alignment in cross-functional and multicultural environments.
Ability to communicate effectively, both verbally and in writing across all levels and functional areas within the organization with strong stakeholder engagement.
Excellent prioritization and organizational skills, with attention to detail and ability to manage competing priorities.
Strong team facilitation skills with the ability to establish collaborative environments and drive alignment across deliverables.
In-depth knowledge of regulatory frameworks, procedures and processes, especially within the EU + EEMEA region.
Proven ability to maintain oversight in the coordination and execution of planning, tracking, assembling, and delivering regulatory components in alignment with regulatory strategy and compliance.
Strong experience in project management methodologies to lead initiatives and streamline planning processes.
Advanced proficiency with complex regulatory IT systems, tools and platforms.
Benefits
Exciting work in a great team, global projects, international environmentOpportunity to learn and grow professionally within the company globallyHybrid working model, flexible role patternPension and health insurance contributionsInternal reward system plus referral program5 weeks annual leave, 5 sick days, 15Health insuranceFlexible schedule
Additional Information
Job Description
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.
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 the ability to lead 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:
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.
Merck · - Central Bohemian - Prague (five), Czechia