Strategic Coordinator for European Regulatory Affairs
2 semanas atrás
About the Role
We are seeking a highly skilled Strategic Coordinator for European Regulatory Affairs to join our team. As a key member of our Regulatory Excellence team, you will play a crucial role in ensuring continuous improvement of end-to-end processes and driving proactive solutions regarding automation, digitalization, or simplification.
Your Key Responsibilities
- Maintenance and optimization of existing SharePoints (over 10) with creation of new SharePoints when needed.
- Prepare and manage all training for PLM Portal, optimizing workflows for the EU platform to meet CHC needs.
- Weekly meetings with PXL to control, explain, and improve workflows.
- Veeva reports creation and maintenance, managing Article 23 reports and setting up a workflow for local notification.
- Manage CmdH notifications, including upcoming WS from the SRF extract.
- C coordinate renewals preparation for MRP/DCP, integrating the way of working into the EU platform.
- Execute regulatory intelligence of EMA website/PLM portal and attend necessary meetings from EMA regarding implementation and shortages notification portal ESMP.
About You
- Bachelor of Science or equivalent required in science or engineering; Master of Science preferred.
- A minimum of 5 years in pharmaceutical industry with demonstrated experience in European regulatory affairs.
- Good level of understanding of regulatory procedures and E2E processes.
- Ability to think strategically and translate business and technical objectives into roadmaps, projects, and data strategies.
- Collaborative approach and ability to cooperate transversally and drive change in Regulatory.
- Excellent interpersonal skills, negotiation skills, and verbal and written communication abilities.
- Ability to lead and drive in a fast-paced team environment and thrive in a global team environment.
What We Offer
- An estimated salary of $80,000 - $120,000 per year, depending on experience.
- A comprehensive rewards package that recognizes your contribution and amplifies your impact.
- Opportunities to grow your talent and drive your career, whether through promotion or lateral move.
- A supportive, future-focused team environment.
About Us
We are Phiture, a company that builds trusted and loved brands connecting with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities while contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.
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