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Regulatory Affairs Associate Director

2 months ago

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

SHATTUCK LABS, INC. is in search of a skilled Regulatory Affairs Associate Director to play a pivotal role in shaping and executing global regulatory strategies for various projects. This position entails managing regulatory submissions, facilitating discussions with regulatory bodies, and ensuring adherence to applicable regulations and internal policies. The successful candidate will possess a robust background in regulatory affairs within the biopharmaceutical sector, particularly with significant submissions such as INDs, CTAs, BLAs, and NDAs.

Key Responsibilities:

  • Offer strategic regulatory insights for international drug development initiatives
  • Oversee the creation of regulatory submissions
  • Clarify and relay regulatory expectations to relevant stakeholders
  • Stay informed about pertinent regulations and guidelines
  • Assist in meeting company and project timelines through timely regulatory contributions
  • Participate 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 regulatory experience in the biopharmaceutical industry
  • 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 biologics development
  • Background in oncology or immuno-oncology
  • Scientific expertise in related areas
  • Ability to excel in a dynamic environment
  • Experience across both early and late-stage drug development
  • Recent involvement with BLA, NDA, and MAA submissions