European Regulatory Affairs Specialist
Há 5 dias
About the Role
We are seeking a skilled European Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Excellence group, you will play a crucial role in ensuring the continuous improvement of end-to-end processes and driving proactive solutions for automation, digitalization, and simplification.
Key Responsibilities
- Maintain and optimize existing SharePoint sites, with over 10 sites to manage.
- Create new SharePoint sites as needed.
- Develop and manage training programs for the PLM Portal, optimizing workflows for the EU platform to meet CHC needs.
- Collaborate with PXL on weekly meetings to control, explain, and improve workflows, including ongoing and upcoming variations.
- Create and maintain Veeva reports.
- Manage Article 23 reports and establish a workflow for local-level notifications, involving Veeva reports, table cleaning, and affiliate contacts.
- Oversee CMDh notifications, including upcoming workshops from the SRF extract to enable early communication during LRC approval.
- Cease renewals preparation for MRP/DCP, integrating the renewal process into the EU platform.
- Manage the ESPM portal at the EU level.
- Monitor regulatory intelligence from the EMA website and PLM portal, attending necessary meetings regarding PLM portal implementation and shortages notification portal ESMP.
About You
- Bachelor of Science or equivalent required, Master of Science preferred for this position.
- Minimum 5 years of experience in the pharmaceutical industry, with demonstrated expertise in European regulatory affairs.
- Strong understanding of regulatory procedures and end-to-end processes.
- Able to think strategically and translate business and technical objectives into roadmaps, projects, and data strategies.
- Excellent interpersonal skills, negotiation skills, and verbal and written communication skills.
- Ability to adapt quickly to changing priorities and meet tight deadlines while maintaining high quality standards.
- Proactive problem-solving and analysis skills, with experience in multitasking and working in a global team environment.
- Familiarity with organizational and intercultural sensitivities, with the ability to apply this knowledge to day-to-day practices.
- Fluent in spoken and written English.
Compensation and Benefits
This exciting opportunity comes with a competitive salary of approximately €80,000 per year, plus a comprehensive benefits package that includes professional development opportunities, a supportive work environment, and a commitment to diversity and inclusion.
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