Regulatory Affairs Project Manager

Role: Regulatory Affairs Project Manager

Team: Regulatory & Strategy Europe

Reporting to: Monika Eck-Schaupp – VP Regulatory & Strategy Europe

Description

Our Project Managers thrive on a challenge, scoping, managing, and supporting the delivery of several complex client projects in parallel. As an essential link between our extensive team of NDA Advisory Board experts, leadership, peers, and clients our Project Managers play a key role in identifying how specific expertise can add extra value to our clients. In collaboration with our Consulting Managers, they create the optimal team to deliver market leading services to our clients.

Our Project Managers possess excellent organisation, time management and project management skills, they are creative problem solvers and decision makers. Working together with our clients they define each project clearly and identify key milestones and project deliverables. Throughout each project they constantly work to find creative solutions, address changing expectations and resolve unexpected project concerns or time restraints. Ensuring a seamless high-quality service.

They have excellent interpersonal and people management skills, proficient in coordinating schedules and input from multiple parties often in multiple time zones.

Key attributes of a successful Project Manager

• Excellent interpersonal, verbal and written communication skills (in English)
• Excellent problem solving capability
• Excellent organisation, prioritisation, project management and delegation skills; with strong attention to detail
• Ability to work independently and collaboratively in a multidisciplinary team
• Capacity to manage high stress situations

Experience and Qualifications

• Education to Bachelor’s/advanced degree level in a scientific discipline
• A minimum of 10 years of relevant experience in Regulatory Affairs or Drug Development
• In-depth knowledge of submission and MAA management and associated processes
• Experience in managing projects in a variety of programs for small molecules, biologics or gene and cell therapy.

As well as being rewarded a competitive salary, we offer a flexible working culture, we truly believe in work/life balance and provide the flexibility to work from one of our offices* or from home depending on your needs and location. We continue to grow year on year whilst maintaining a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation with a local feel.

*(Current COVID guidelines are in place)

Application & Contact

If you are interested in learning more about this role, please click apply with the subject line: RA Project Manager attaching your CV and cover letter.