Regulatory Affairs Associate Director

1 week ago


Durham, North Carolina, United States SHATTUCK LABS, INC. Full time
Regulatory Affairs Associate Director

SHATTUCK LABS, INC. is on the lookout for a skilled Regulatory Affairs Associate Director to play a pivotal role in shaping and executing global regulatory strategies for designated projects. This position entails managing regulatory submissions, facilitating discussions with regulatory bodies, and ensuring adherence to industry regulations and organizational policies.

Key Responsibilities:

  • Deliver strategic regulatory insights for global pharmaceutical development initiatives
  • Oversee the compilation and submission of regulatory documents
  • Clarify and convey regulatory requirements to various stakeholders
  • Stay informed about pertinent regulations and guidelines
  • Support project timelines by meeting regulatory obligations
  • Assist in the formulation of policies and procedures
  • Collaborate effectively with both internal teams and external partners

Required Qualifications:

  • Bachelor's Degree in a relevant field
  • A minimum of five years of experience in regulatory affairs within the bio/pharmaceutical sector
  • Demonstrated success in regulatory submissions
  • Familiarity with FDA and ICH regulations
  • Experience in drug development and clinical trial design
  • Strong judgment in communicating issues

Preferred Skills:

  • Experience in the development of biologics
  • Background in oncology or immuno-oncology
  • Scientific expertise in relevant disciplines
  • Ability to excel in a dynamic work environment
  • Experience across both early and late-stage drug development
  • Recent involvement with BLA, NDA, and MAA submissions


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