Support the development of the nonclinical / clinical regulatory strategy and plan.

Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.

Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.

Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.

With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.

Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidances.

Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports) Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.

Collaborate with Reg PM to create and align submission timelines, Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.

Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.

Organize and maintain the administrative, nonclinical, and clinical portions of IND's, NDA's and BLA's.

Oversee the archiving of HA submissions and correspondence

Keywords:

Education:

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience

4 + year experience with PhD; 6+ years with Master's or bachelor's degrees Nonclinical / Clinical Regulatory Affairs experience preferred