Director/Sr Director Regulatory Affairs

​About the Job

Director/Senior Director Regulatory Affairs

Boston, Ma (on site)

Full time permanent

Responsibilities

• Prepare and submit INDs and IND amendments and other regulatory submissions.

• Defining, preparing and providing required module 3 content for submissions.

• Author and Review CMC development reports, batch records and other technical reports.

• Participate in interactions with FDA for assigned projects.

• Maintain a knowledge in the specific areas related to GCP, GLP and GMP compliance.
  

Qualifications

• Bachelor's degree with 12 or more years of experience at a CRO, a sponsor company or in the Pharma/Biotech industry.

• Working knowledge of U.S. Federal Regulations related to clinical research.

• Strong knowledge of submission compilation in eCTD format.

• Understanding of GMP/manufacturing requirements.