Regulatory Affairs Manager CMC, Xspray Pharma

Do you know regulatory CMC within pharma? Would you like a global headquarter position with strategic, tactical, and operational responsibilities? We are close to launch of our first product and are expanding the regulatory team.

Xspray Pharma’s technology is based on supercritical fluid that simultaneously exhibits both liquid- and gas-like properties. The active substance is combined with excipients to create a solid dispersion - a fully amorphous form with a significantly higher solubility & bioavailability than the original. Xspray primarily develops protein kinase inhibitors (PKI) for targeted cancer treatments.

As Regulatory Affairs Manager you will be responsible for regulatory CMC activities. Your responsibilities include, but are not limited to:

- Develop and implement regulatory strategies
- Communication with medical product agencies. At present mainly FDA in the US.
- Review and write CMC dossier documents for applications, other regulatory documentation, and SOPs
- Assist with regulatory input, coordinate regulatory projects and collaborate with e.g. product developers, analytics, production/CMO and external consultants.
- Compile IND and annual reports
- Ensure that product information is created and updated
- Stay up to date on new regulations and guidelines, update and implement changes


Xspray Pharma is close to the first marketing authorisation and have several projects in the pipeline. The job is varying, challenging and you will be able to work independently, yet in a team of experienced specialists. To us, everyone working here is essential and we have an open and friendly atmosphere.

Location: Solna

Terms of employment: Open-ended position at Xspray, full-time.



Qualifications requirements
- Academic degree within science or relevant technical discipline
- Extensive knowledge of regulatory CMC requirements and guidelines in late phase pharmaceutical development and/or commercial phase
- Experience from working cross functional with e.g. QA, product development, analytical chemistry and production
- Very good written and spoken English


Meriting qualifications:

- Experience from FDA/the US and hybrid/generic applications
- Experience from developing regulatory strategies


Is this you? Welcome with your application!



Application & more information
In this recruitment Xspray is working with Search4S. For more information contact Recruitment Consultant Anna Rennermalm, +46 707 94 20 05 or anna@search4s.se.

Last application date: 20 Sep 2022

Interviews and selection of candidates will be continuous.

About Xspray
Xspray was founded in 2003 as a drug delivery company based on the company’s patented nozzle for particle engineering and scale-up. In 2011, Xspray realigned its business model from conducting contract research and development for other pharmaceutical companies to focusing on developing proprietary drugs based on its RightSize™ technology. Xspray is now a pharmaceutical company focused on developing improved versions of already marketed drugs, mainly protein kinase inhibitors (PKIs) for targeted cancer treatments.

Xspray has announced three product candidates in development, with a clear path to launch the products in the US. The original drugs had in 2019 annual sales of over USD 2 billion in the US alone.

Xspray is located in Solna. Today, we are 30 people and rapidly growing.

www.Xspraypharma.com