Director of Regulatory Affairs

Leyden Labs is currently looking to hire a seasoned

Director of Regulatory Affairs

In this role you are responsible for the development and successful execution of regulatory strategies, plans and processes for our infectious disease programs. You will be part of a variety of projects, where you’ll be the expert regarding RA. With your expertise and knowledge, you will actively advise the project teams to ensure that Leyden Labs’ programs meet all applicable regulatory and business requirements. In this role, you will be reporting to our CMO.

To be considered for this role, you must have experience as a Regulatory Affairs specialist in Europe and the US. You can take the lead, are used to presenting to and discuss with local and international authorities. Internally, you promote open dialogue to investigate the various options and then work towards a position balancing the various risks and opportunities, externally you have a compelling presence in representing the company and its programs. You feel comfortable making decisions and have a hands-on attitude.

This is what you will do on a daily basis and these are your responsibilities:

• Lead the development and implementation of a regulatory strategy for our different product programs
• Apply in depth understanding of regulatory requirements and trends to our programs
• Ensure the successful adoption and execution of appropriate regulatory strategies and processes and be aligned with short and long-term business strategies and goals
• Collaborate with management to provide oversight on regulatory matters; and where needed, direct the contributions to meetings with regulatory authorities, key opinion leaders and similar experts and bodies
• Guide Leyden Lab team members on challenging, complex regulatory and decision-making issues. Share relevant information and drive development of viable strategies and/or methodologies which reflect the most up-to-date regulatory and compliance standards
• Identify and escalate where appropriate to resolve significant issues and risks