| Descrizione |
ER Services Sagl is looking for a REGULATORY AFFAIRS SPECIALIST for its' client, a pharmaceutical company in Lugano.
The candidate, a Regulatory Affairs Strategist for substance-based medical devices according to Regulation (EU) 2017/745 of the European Parliament (MDR), will be responsible for developing and implementing cross-functional strategic plans and to prepare the documentation for incoming registrations of new products in new therapeutic areas, in collaboration with Company's team.
Responsibilities
. Regulatory lead for business-critical new product development projects and external partnership programs; including oversight for product lifecycle management ensuring that the state-of-the-art requirements are maintained.
. Work with Notified Bodies to establish least burdensome regulatory strategies/paths to validate desired product claims.
. Manage schedules for regulatory submissions, coordinate the preparation and staging of all regulatory documentation, and actively monitor and track submissions under review.
. Lead Notified Bodies interactions for products under review, ensure timely responses and communications, and successfully navigate through the process to secure registrations.
. Collaborate globally and cross-functionally (e.g., Medical Affairs, Business Development, Quality Assurance, R&D, Marketing department) to define regulatory strategy and plans for clearance / approval of company projects intended for new therapeutic areas.
. Manage US and International regulatory requirements and proactively manage impact to projects current and future portfolio.
. Actively participate in project core team meetings and drive to collaboratively achieve project goals and meet timelines.
. Critically support analytical and clinical study protocols and reports to assess quality, to identify gaps, and provide mitigations.
. Provide periodic updates on status of projects to larger cross-functional audience and leadership.
. Prepare content for technical files.
. Manage Artwork (text, design, etc) for Company's partners and Company's portfolio.
. Ensure compliance with the current regulatory procedures and where needed.
. Manage the product registration in the various countries and support the partner and Company's team during the due diligence.
. Responsible for the execution, monitoring, and analysis of the agreed tactical plans to ensure the development and registration of the products.
Requirements
Degree in Science or Engineering.
. 5+ years relevant experience in regulatory affairs substance-based medical devices.
. 5+ years working in the pharma or similar industries.
. Understand how health authorities make decisions and how regulatory procedures, submissions and data standards impact the product development lifecycle.
. Previous experience interacting with health authorities (e.g. Notified Bodies) in the US & EU.
. Exceptional communication and organizational skills.
. Cross Cultural Experience.
. Deep understanding of Brand Management.
. Project Management expertise.
. English is a must.
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