Job Description
The Regional Submission Planner Associate Specialist will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations (RRO) department, supporting regional planning activities for the EU + EEMEA region and other regions, as needed.
The role provides operational and administrative support to Regional Submission Planners to help ensure regulatory submissions are planned, tracked, and executed efficiently and compliantly. The incumbent supports planning activities through data maintenance, quality control reviews, system updates, report generation, documentation management, and coordination of routine operational tasks.
Working under the guidance of experienced planners, the Associate Specialist contributes to the integrity of planning data, supports submission readiness activities, and participates in continuous improvement initiatives while building knowledge of regulatory operations and submission planning processes.
Specific responsibilities include:
- Supporting Regional Submission Planners with day-to-day planning and operational activities.
- Performing administrative activities related to submission planning, tracking, and documentation management.
- Maintaining and updating regulatory planning systems, databases, trackers, and repositories to ensure data accuracy and completeness.
- Conducting quality control (QC) reviews of planning data, timelines, submission records, and associated documentation.
- Supporting the collection, consolidation, and maintenance of submission-related information required for planning and reporting purposes.
- Assisting in monitoring submission milestones and tracking deliverables against established timelines.
- Preparing routine planning reports, metrics, dashboards, and status updates for planners and stakeholders.
- Supporting the preparation and maintenance of planning documentation, meeting materials, action trackers, and process documentation.
- Assisting with registration tracking activities and ensure information is accurately reflected in applicable systems.
- Supporting submission readiness activities through coordination of required administrative and operational tasks.
- Identifying data discrepancies, system issues, or missing information and escalate appropriately to experienced planners.
- Participating in process improvement initiatives aimed at improving planning efficiency, data quality, and operational effectiveness.
- Developing knowledge of submission planning processes, regulatory operations, and regional regulatory requirements through training and on-the-job learning.
Qualifications
- Bachelor’s degree or equivalent experience in life sciences, pharmacy, regulatory affairs, business, or a related field.
- Entry-level profile; previous internship, apprenticeship, or up to 1 year of experience in the pharmaceutical industry, project coordination, regulatory affairs, supply chain, operations, or another regulated environment is desirable.
- Experience working with project plans, timelines, tracking tools, or data management activities is considered an advantage.
Desired skills
- Strong organizational skills with the ability to manage assigned activities, follow timelines, and prioritize tasks effectively.
- Strong attention to detail and commitment to quality, accuracy, and compliance.
- Strong verbal and written communication skills in English.
- Ability to work collaboratively and respectfully in a matrix, multicultural, and cross-functional environment.
- Problem-solving mindset with the ability to identify issues and support resolution under guidance.
- Ability to learn new processes, systems, and ways of working quickly.
- Familiarity with Microsoft 365 applications, including Outlook, Excel, PowerPoint, Teams, and SharePoint.
- Ability to learn and leverage regulatory systems, digital tools, and AI technologies to support planning and operational activities.
- Comfortable working with data, maintaining records, tracking information, and performing quality control activities.
- Awareness of the importance of working within procedures, guidelines, and regulatory requirements.
- Interest in regulatory affairs, submission planning, and pharmaceutical operations.
- Interest in continuous improvement, operational excellence, and process optimization, with a curiosity to identify opportunities for improvement.
- Basic project coordination skills and interest in developing project management capabilities.
- Basic understanding of organizational structures and the ability to quickly learn internal processes and ways of working.
Additional location(s) Compensation Information:
Required Skills:
Adverse Event Report, Adverse Event Report, Audits Compliance, Continuous Improvement Techniques, Data Quality Assurance, Document Control Systems, Document Management, Electronic Common Technical Document (eCTD), Employee Training Programs, Microsoft Dynamics 365 Customer Relationship Management (CRM), Microsoft Identity and Access Management (IAM), Microsoft Office, Microsoft SharePoint, Office 365 Administration, Organizational Effectiveness, Pharmaceutical Industry, Pharmaceutics, Policy Implementation, Prioritization, Process Improvements, Project Management, Project Planning, Quality Control (QC), Records Retention Management, Regional Planning {+ 8 more}
Preferred Skills:
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
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Hazardous Material(s):
Job Posting End Date:
11/9/2026
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