Requirements: English
Company: Sanofi EU
Region: Budapest , Budapest
- Location: Budapest, Hungary
- Job type: Permanent, full-time
- Hybrid working
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Join our Global Regulatory Affairs Submission Excellence team as a Regulatory Project Coordinator (RPC) and you will be leading / contributing to the end-to-end planning, coordination, and execution of assigned tasks. You will understand and implement regulatory, technical expertise and guidance on procedural and documentation requirements to the Global Regulatory Team and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
The RPC creates integrated regulatory plans and timelines in support of Health Authority regulatory filings and interaction plans and timelines for all regulatory deliverables, manages Veeva operations, coordinates reviews/approval processes for regulatory-owned deliverables, organizes appropriate quality reviews, edits, and copyright compliance are performed, and provides purposeful communication to the Global Regulatory Leader and Regulatory Strategist, particularly if issues are encountered.
Support operational and compliance activities in Veeva for assigned deliverables by developing, executing, and maintaining regulatory objectives, submission content plans, and document launch and management workflows.
Main responsibilities:
Support operational and planning activities related to Health Authority and Competent Authority submissions, including preparation, and monitoring the execution of the integrated project and submission content plans for both simple (i.e., meeting requests, briefing packages, designation requests, pediatric plans, etc.) and increasingly more complex submissions (INDs, NDAs, BLAs, etc.).
- Project management tasks that support the Global Regulatory Team (Common Technical Document, Global Submission Strategy, Investigational New Drug amendments, planning for Health Authority meetings, support when preparing for internal committees).
- Organize preparation of Kick-Off Meeting with Global Regulatory Team to align on expectations and expected/realistic timelines for regulatory-owned submissions.
- Coordinate with the Global Regulatory Leader for the input, maintenance, and revision of Research and Development Portfolio Management project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Global Regulatory Leader, as needed.
- Veeva Vault RIM tracking:
- Create Regulatory Objectives.
- Create Submission Content Plans (SCP). - Input submission records, Health Authority Questions/Answers, and data entry (particularly HA interactions required to be uploaded within 5 business days of receipt).
- Document management in Veeva:
- Launch Document Template.
- Assign Author/Review/Approval Workflows.
- Supervise Quality Review and Editorial ReviewResources.
- Manage Copyright Compliance for References.
- Formatting /finalizing documents prior to publishing.
About you
Experience:
- Basic drug development experience within the biopharmaceutical industry, clinical site setting, or at a health authority, or other relevant experience.
- Experienced in the pharmaceutical industry, with direct regulatory affairs experience and Or Clinical development and/or project management in a global and matrix environment preferentially in R&D.
- Experience in dossier preparation and maintenance, registration, submissions/ submissions planning for EU/ US/ Global regulatory lifecycle marketing authorization experience is desirable.
Soft Skills:
- Ability to work with autonomy and as part of a team.
- Excellent experience in stakeholder management and project management.
- Highly organized: able to multi-task (i.e., work on several initiatives at same time).
- Ability to participate in multi-disciplinary and diverse teams and interface. Ability to communicate and collaborate on many levels, including issue escalation to leadership.
- Ability to work across cultures with strong interpersonal skills to be effective in global teams with customer focus and action orientation.
- Str