02 Nov
Associate Director, Regulatory Affairs
Maryland, Gaithersburg , 20877 Gaithersburg USA

Job Description

  • Serve as an empowered US Regulatory Lead of the assets for the Therapeutic Group(s) focusing on Immunology and Immuno-oncology;
  • Serve as point of contact for Regulatory Agencies between US and China teams;
  • Lead US IND filings with high quality and expedited fashion. Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders;
  • Assist in preparation and submission of INDs and IND amendments;
  • Assist in preparation and submission of international Clinical Trial Applications;
  • Participate in the development and implementation of short- and long-term Regulatory plans for key projects;
  • 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.;
  • Lead preparations and delivery of FDA communications with Clinical Development Team;
  • Provides regulatory due diligence into business opportunities as needed.

Qualifications

  • Regulatory Affairs experience in drug development and/or registration activities is a must.
  • Minimum of a Bachelor’s Degree in an applied science field. Ph.D degree is highly preferred.
  • Outstanding working understanding of the U.S. regulatory environment.

Additional Information

All your information will be kept confidential according to EEO guidelines.


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