Overview
Skills
Job Details
Sr. Regulatory affairs
Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.)
Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulatory landscape in hopes of getting their drug(s) approved for commercialization here in the US.
This role will report into the SVP of Clinical Development.
Key Responsibilities
Provide guidance and strategic direction for regulatory submissions and FDA interactions/communications
Support FDA, MHRA, EMA, and MRCT consultations
Partner with clinical development, clinical operations, and other various cross-functional teams to drive regulatory compliance
Qualifications
Bachelors Degree required, Advanced degree preferred. RAC strongly preferred
10+ years of relevant experience (Associate Director to Executive Director level consultants)
Extensive experience with NDA and BLA regulatory submissions with prior experience interacting and communicating with the FDA.
MHRA and EMA experience. Candidates will need to have experience with MRCT (Multi Regional Clinical Trials)
Oncology drug experience, specifically with XDC's or ADC's (drug conjugates)
The client is seeking candidates who are energetic, dedicated to the science, and have a "can-do" mentality. The client has aggressive timelines with respect to patient enrollment and regulatory submissions.