Early Access Program - Regulatory Affairs (EAP-RA)

What is the company like?

With a unique combination of Early Access Programs (EAPs), Clinical Trial Supply (CTS) and Clinical Development, this global CRO is a pioneer in delivering life-changing medicines to patients worldwide. They take pride in their core principles of trust and belonging which underpins their welcoming, flexible, and supportive culture. They are passionate about ensuring that you have what you need to produce your best work. It is for this reason that care so much culturing the right environment that facilitates personal well-being and development.

Their benefits are aligned with their culture and values and are intended to maximize your experience working for them. Here are some of the benefits you can expect from working for at this company:

• Competitive number of vacation days each year + option to purchase more
• 1 volunteer day per year
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Employee Support Networks
• Flexible and hybrid work
• Training and Personal Development Program

What qualities do you need to be successful?:

• Academic background in Life Sciences
• Proven experience in regulatory affairs in either a CRO environment (preferred) or within the pharmaceutical industry
• Early Access Programs experience is essential (experience in Managed, Expanded or Compassionate access/use programs is also appreciated)
• Experience in drug development
• Clinical trials regulatory experience
• Diligent team player with attention to detail and good communication skills
• Ability to work independently

What will your job look like?

• Prepare, compile and review regulatory documentation in support of regulatory submissions for both investigational and commercial medicinal products
• Contribute to daily regulatory affairs activities to ensure compliance with relevant regulatory obligations
• Ensure the compliance of both internal and external quality systems with EU regulatory requirements
• Advise pharmaceutical and biotechnology clients on EU regulatory strategy and requirements for investigational and marketed products
• Participate in client meetings and liaise with said clients regarding ongoing projects
• Organise meetings and generate associated briefing materials in preparation for meetings with all relevant regulatory authorities
• Support our employees and vendors, who are engaged in regulatory service activities on behalf of either clients or ourselves

If you are inspired by changing the lives of patients all over the world, we’d love to hear from you! - Even if you don't quite meet 100% of these requirements, please do still apply.

This company has ambitious expansion plans for their RA-EAP team so they are interested in hearing from anyone who has an EAP track-record.