Senior Manager, Regulatory CMC, Switzerland
Senior Manager, Regulatory CMC, Switzerland, Small molecules, Global submissions
Great opportunity to join a fast growing pharmaceutical company who have many new products coming to both the US and EU markets. The company have a strong focus on acquiring established pharma rx products and have many more deals lined up. With this in mind it's interesting for someone wanting to be more involved in commercial regulatory affairs as there will be many projects covering tech transfers, working with new CMOs and dealing with new formulations. In addition to this the product regional spread includes both Europe and the US, hence there is an opportunity to be involved with FDA processes.
From a company perspective, I have worked with this client for nearly 7 years, hence I can give fair case studies and examples of what it can be like to work there. It certainly is a great place to learn and develop. We have placed many candidates who have been working for over 5 years and have had multiple promotions. Working in a fast paced company is always challenging and is not for everyone, but certainly it offers an environment different to the norm in Switzerland.
- Preparation, writing and review of key CMC documents
- Be a key part of the overall regulatory team
- Project leadership for certain products and regions related to CMC
- Close collaboration with QA, Tech Transfer teams and external suppliers
- Replying to and working with health authority interactions
- Life Science degree
- Strong experience in regulatory CMC, specifically we need someone who can write CMC (module 3) for small molecules
- Broad pharma regulatory experience
- Fluency in English, company language is English
Open to relocators? Yes, we can consider candidates who are EU citizens.
For a confidential discussion about this role, or to apply, then send your CV to email@example.com or call me, Matt Beedle, Associate partner for Switzerland on +41435 080817. Please feel free to visit my linked-in profile to see my references/recommendations.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.