Join Our Team
Are you a dedicated and driven Regulatory Affairs professional with 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: Senior or Principal Consultant
Team: Regulatory & Strategy US
Reporting to: Kim Forbes-McKean – SVP Regulatory & Strategy US
We are looking to expand our US Regulatory & Strategy team with a Senior or Principal Consultant in Regulatory Affairs who have experience working on a variety of programs including, small molecules, biologics or gene and cell therapy. Experience in oncology and/or rare diseases is a plus.
Responsibilities
As a Senior or Principal consultant at NDA Group you will provide strategic and operational regulatory support within drug development on a global, regional or national level. You will manage and contribute to a variety of complex projects working with large international companies and small local start-ups.
You will be involved in interactions with clients, internal colleagues and regulatory agencies. The work is wide-ranging, and you will have a great opportunity to develop professionally.
Qualifications / Experience
- A minimum of 10 years of relevant experience in US Regulatory Affairs
- Experience in leading the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies
- Experience and up-to-date knowledge of US regulatory procedures and changes
- Direct interaction with FDA
- Expertise in a specific area of development: Regulatory Affairs, CMC, Nonclinical or Clinical
- Extensive expertise with regulatory related development procedures (e.g., Pediatric Development Plans, Fast Track, Breakthrough or Orphan Drug Designation).
- Knowledge of ex-US regulatory procedures is desirable, but not required
- Proven ability to lead cross functional teams
- Ability to work independently
- Excellent communication skills
We are looking for someone who sees the value in teamwork and is comfortable leading complex client projects in a fast-changing international environment.
Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible.
Contact us
Your drug development needs are unique
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.
Let's Bring Medicines to the World