Director/Senior Director, Regulatory Affairs

Location: Washington, District of Columbia, United States
Salary: competitive
Job Type: Permanent
Apply for this Job

This is an excellent opportunity for an experienced Regulatory Affairs Operations professional to join a well-funded biotech which has just listed on the NASDAQ, and who is looking to double their USA headcount over the next 12 months. Having raised over $400m, and with an impressive business established in China, it is an excellent time to join as they globalize their operation.

You will be responsible for all regulatory operations and document management in the USA for this biopharma as they grow their stock price on the NASDAQ and attract top talent across the USA. Longer term they have a healthy pipeline of oncology biologics and are preparing to submit an IND by the end of the year.

Responsibilities:

  • Serve as U.S. and global regulatory lead for immunology and immuno-oncology pipeline
  • Point of contact for regulatory agencies in the US and China
  • Lead IND filings
  • Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs
  • Perform nonclinical, CMC and clinical GAP analyses of dossiers being considered for registration of products in the U.S.

Sthree US is acting as an Employment Agency in relation to this vacancy.

Apply for this Job