Regulatory Affairs Manager
This position has responsibility for Regulatory Affairs in defined portfolios or activity streams for the Swiss market. This includes:
• Ensure products within scope (mainly medicines, also devices, cosmetics and foods) can be placed on the market with optimal and compliant claims and in line with commercial plans
• Ensure products are maintained and meet internal and external compliance requirements
• Be a productive part of local regulatory team, including being a proactive partner to other stakeholders, e.g. marketing/sales, quality and supply chain
• Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges
• Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK with local regulators, trade associations and other key external regulatory bodies
• Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
• Manage preparation and submission of new regulatory applications to enable new products to be launched and maintained in Swiss market, with correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
• Manage all activities to ensure maintenance of authorised products
• Ensure timely preparation and implementation of packaging material and patient information according artwork procedures, and ensure high quality translation of health professional and patient information into local languages.
• Build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK policies and strategies
• Ensure compliance within defined portfolio/activity in line with GSK expections and regulations
• Work together with other functions (global and local) on differnt projects e.g. innovation
• Proactively manage impact of regulatory changes within defined scope of responsibility on the business
• Maintain required regulatory compliance databases, systems, archives and processes
• Maintain high level of knowledge on the science of products within defined portfolio
- Master degree in Pharmacy or other Life science / Pharmaceutically-related science, Regulatory Affairs
- Ideally 3 - 5 years' experience in Regulatory Affairs
- Required Languages: German mother tongue and fluency in French and English
- Good knowledge of relevant Swiss legislation and OTC market environment
- Knowledge of Italian language
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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