Job Description :
Position :DRA Operation Manager

Location :Marlton, NJ

Interview Mode :Phone and face to face or Skype

Duration:9 months+

Job Description:

- At least four years'' experience in regulatory affairs operations

- Sound knowledge of FDA regulations and guidelines

- Contribute to and support the overall compilation and submission of complex health authority

submissions (initial IND, NDA and sNDA, drug listing, and maintenance activities for both IND and NDA) for assigned projects in the applicable format (eCTD or paper) using appropriate tools

- Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure (with guidance from authors where necessary), building XML backbone, eCTD leaf titles, and lifecycle operators in accordance to company procedures and standards.

- Proofread, submit and track product labeling and coordinate the internal distribution process for

assigned projects

- Provide quality control of eCTD submissions prepared by other DRA Operations NJ staff

- Responsible for daily prioritization for assigned projects and escalating issues to DRA Operations

Group Leader and for communicating project related activities to other assigned DRA operations


- Responsible to ensure DRA Operations Associate is aware of study progress in