|
This is an excellent opportunity
for an experienced candidate knowledgeable with eCTD
publishing. We are currently seeking
candidates with a minimum of 3-5 years experience.
Advance technology experience is a plus.
JOB SCOPE
-
Prepare regulatory submissions: including INDs,
ANDAs, & NDAs.
-
Provide regulatory counsel on submission strategies
(both internally and externally for
clients/customers).
-
Lead
the company toward fully electronic submissions.
-
Guide
Informatics to identify and procure the appropriate
hardware and software to keep the company updated
with eCTD requirements.
-
Maintain/update a training curriculum on eCTD
submissions.
-
Select
vendor(s) to support eCTD readiness, implementation
activities, and training.
-
Interact with counterparts in CRO's and development
partners on electronic submission/eCTD issues.
-
Interface with the FDA to receive expert advice on
electronic submissions.
-
Oversee the Regulatory Submissions Group and ensure
timely coordination and publishing of various
regulatory submission documents.
REQUIREMENTS
-
Minimum BS degree in Life Science or Health related
field (Pharmacy, Chemistry, Microbiology, or
Biology).
-
3-5
years experience in regulatory submissions and at
least 2+ years experience in electronic submissions
for the pharmaceutical industry.
-
CoreDossier is essential to create and manage eCTD
electronic submissions.
-
Expert
knowledge of ICH/FDA eCTD specifications.
Working knowledge of EU eCTD specifications a plus.
-
At
least one year of experience in leading successful
electronic submission of INDs or marketing
applications.
-
Experience with the preparation of INDs, NDAs.
-
Understanding of new drug regulations.
-
Excellent written and oral communication skills,
excellent organizational skills, and strong project
management skills required.
|