Job Title: Regulatory Affairs Associate
Date Posted: 11-15-2006
Job Location: Massachusetts-Boston
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 2+ to 5 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Idenix Pharmaceuticals
Company Website:
Contact Information: Idenix Pharmaceutica   Idenix Pharmaceutica (
Job Description:

• 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
line-function level

• Assist in authoring SOP’s 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
disability insurance.

To be considered for this position, please send your resume by email to , or by
mail to:

Human Resources
Idenix Pharmaceuticals
60 Hampshire Street
Cambridge, MA 02139 
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