Provide in-depth strategic & technical advice regarding electronic regulatory submissions
(e-INDs; e-NDAs; e-CTDs etc).
Provide regulatory review & feedback regulatory submission plans and timelines.
Present regulatory/technical information at both internal and external meetings.
Under limited supervision, design and complete strategic regulatory submission plans for
assigned projects, and interface with contractors as needed.
Capture legacy submissions, amendments, and foreign health authority communications in the
Develop and initiate training program to ensure proper use of documentation system at the
Assist in authoring SOPs governing electronic submission procedures (Annual Reports,
Amendments, Protocols, etc)
Prepare, review, and compile regulatory applications including investigational and marketing
applications (IND, CTA, CTX, NDA, NDS, MAA, etc.), amendments, supplements, periodic reports,
annual reports, and drug master files.
Assist with Idenix e-submissions regulatory infrastructure.
BS Life Sciences.
Minimum Work Experience:
Prior experience in regulatory affairs (2-4 years).
Must have experience and understanding of regulatory submission requirements for drugs.
Previous experience working on an eNDA, eBLA, or eCTD.
Idenix offers an excellent benefits package including competitive salary, equity compensation,
major medical insurance, dental insurance, 401(k) plan participation, and group life and
To be considered for this position, please send your resume by email to firstname.lastname@example.org , or by
60 Hampshire Street
Cambridge, MA 02139