Associate Director, Regulatory CMC

Seeking an Associate Director in Regulatory, CMC to independently lead, contribute and execute on CMC regulatory activities in support of Deciphera’s studies across all stages of clinical drug development. The primary responsibility will be to generate high quality and compliant CMC regulatory submissions for global investigational applications, initially focusing on oligonucleotide products. This position will report to the Senior Director of CMC Regulatory and will be a hybrid role based out of our Waltham, MA office. Additionally, opportunities will include contributing to CMC regulatory activities in support of other Deciphera small molecule and biologics programs and studies across all stages of clinical drug development. Collaborate with CMC cross-functional team members to plan, write and review CMC sections of pertinent regulatory submissions. Provide regulatory guidance to cross-functional team members on required content of Module 2/Module 3. Review documentation in support of CMC and QA activities for drug development programs. Review and assess proposed CMC changes during drug development for regulatory impact and filing requirements Communicate with regulatory Health Authorities on project related matters. Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation. Review industry guidance and pharmacopoeia updates to ensure cross functional alignment with current practices and regulations.