Join Our Team
Are you a dedicated and driven Project Manager with Regulatory Affairs or drug development experience? Do you want to be part of a global team and utilize your experience and knowledge to help ensure that good medicines get to those who need them without unnecessary delay?
Role: Regulatory Affairs Specialist (Project management experience required)
Team: Regulatory & Strategy Europe
Reporting to: Ben Continsouzas – Director Integrated Development Strategy
We are looking to expand our team with a Project Manager who has experience in Regulatory Affairs. This is a global position with the possibility to work from one of our offices in Europe or US. We are looking for someone who sees the value in teamwork and is comfortable leading complex client projects in a fast-changing international environment.
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 at NDA
- 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
Required Experience & Qualifications:
- Education to Bachelor’s/advanced degree level in a scientific discipline
- A minimum of 10 years of relevant experience in Regulatory Affairs
- 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.
- Experience working in an agency
- 5 years relevant experience in Drug development
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 believe it is important that every person with us is allowed to continue to develop. That is why we set individual goals with all our employees and adapt customer assignments and tasks accordingly.
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, contact us at Recruitment@ndareg.com with the subject line: Regulatory Affairs Specialist (PM) attaching your CV and cover letter.
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Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
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