Regulatory Affairs Specialist/Manager

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

  • Draft and manage regulatory documents and submissions in eCTD via ESG to FDA inc
  • Reports/DSUR to INDs, Investigator's Brochures (IBs), information amendments (nonclinical, clinical, and CMC), and any other regulatory dossiers;
  • Review regulatory documents for their compliance with pertinent guidance and technical preparedness, including nonclinical CMC reports, general investigational plan, and IB, etc;
  • Assist to manage timelines for the drafting, review, revision, and submission of regulatory dossiers;
  • Track on-going regulatory activities and plan for up-coming ones with the key contributors from cross-functional team to ensure timely delivery of regulatory items;
  • Support the development of the Standard Operating Procedures (SOPs) of Regulatory Affairs;

Salary upon enquiry

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

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