Our client is a pharmaceutical company in the commercial phase, focused on the late-stage development and commercialization of prescription medications in Europe and Switzerland.
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Tasks
Development and Execution of Regulatory Plans
* Develop and implement regulatory plans aligned with the company’s products and objectives.
* Prepare and submit regulatory documentation, including approval applications, amendments, renewals, or responses to authorities' inquiries.
* Ensure that documents from partner companies meet required standards and are submitted on time.
* Establish and maintain professional relationships with regulatory authorities, including participating in meetings, supporting inspections, and addressing inquiries.
Cross-Functional Collaboration
* Coordinate regulatory processes with departments such as pharmacovigilance, medical functions, quality assurance, and marketing to ensure consistent outcomes.
* Support quality assurance teams and responsible personnel in monitoring manufacturing processes, technical requirements, and contract management.
* Provide guidance and review labeling, advertising, and marketing activities to ensure compliance with national and international regulations.
* Assess business opportunities from a regulatory perspective and contribute to strategic product development.
* Implement an accessible and well-organized system for storing regulatory documents.
Continuous Learning and Networking
* Build and maintain a network with external partners and industry representatives to foster regulatory collaboration.
* Stay updated on changes in regulatory requirements and legal standards for product development and commercialization.
Reporting
* Work directly with the regulatory department leadership and provide regular updates.
Requirements
* Degree in a relevant field such as life sciences or pharmacy (advanced degree preferred).
* At least 5 years of experience in a regulatory role within the pharmaceutical or biotechnology industry.
* Proficient in German and English; additional language skills are an advantage.
* In-depth knowledge of regulatory requirements in Switzerland and ideally other European countries.
* Proven experience in organizing and implementing complex regulatory projects and liaising with authorities.
* Strong communication skills and team spirit for collaboration with interdisciplinary teams.
* Strategic and analytical mindset to develop innovative solutions for regulatory challenges.
* Ability to prioritize tasks and work efficiently in a dynamic environment.
Benefits
* 5 Weeks vacation
* Annual Company Event
* Bonus payment
* Company workshops and knowledge exchange
* Flexible working hours
* Startup culture
* Company car (depending on the position)
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