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Director/Senior Director Regulatory Affairs

Company

RBW Consulting
Address United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-09-02
Posted at 9 months ago
Job Description

Role: Director/Senior Director Regulatory Affairs (Remote)

Job Ref: AFRWB5

Location: Remote, USA

Type: Permanent / Full Time


We are partnered with a Market-leading Oncology biotech, who are seeking to add headcount within their growing Regulatory Affairs team.


Following numerous product launches globally, our client is looking to bring on a Director AND Senior Director of Regulatory Affairs. The ideal candidate will ideally have a proven experience in this space, including exposure in Phases 1-3, as well as a background in Oncology and Solid tumors.


With an extremely successful pipeline and multiple products on the market, our client has been growing rapidly, with an extensive pipeline in development phase. Therefore, this position is a great opportunity for someone to develop their career in a fast-paced environment, with great opportunities to develop longer term.


The successful candidate will be a key Regulatory hire in the US team and will be working with other key stakeholders (internally and externally) to advance the company's portfolio. This position offers an amazing opportunity to spearhead the Regulatory function and work on a variety of pivotal-stage submissions as well as getting exposure to products ranging from Pre-IND to Post-Approval Maintenance.


Skills / Experience required:


  • Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)
  • Success in filing IND's/CTA's in Oncology
  • Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.
  • Direct exposure to FDA/EMA etc. Interactions
  • 7-10+ years Regulatory Affairs experience
  • Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)


If this opportunity aligns with what you're looking for next, please reach out to Andrea Fratus at RBW Consulting to discuss the role in more detail. Feel free to reach out via email at:

[email protected] | 619.489.4498