THIS JOB HAS EXPIRED Reporting to the Vice President, Regulatory Affairs, this position will have overall responsibility for coordinating and preparing NDA/MAA and IND/CTA submissions to regulatory authorities.
Coordinating and compiling documentation in support of NDA, and MAA filings
Assisting in the development of regulatory strategy both in the US and ex-US, including strategic input into submission content
Provide regulatory input into cross-functional Project Teams for product development and submission activities
Interacting with US and ex-US regulatory agencies
IND/CTA maintenance (information amendments, SAE reports, annual reports, meeting notes, etc.)
Coordinating with consultants and CROs assisting with submission activities
Responsible for communications and oversight of CROs preparing electronic submission documents
Oversight of archiving of regulatory documents & correspondence files, in both electronic and hard copy formats.
Creation and maintenance of regulatory project logs/databases, tracking the submission status of reports and other regulatory activities.
Bachelor?s degree (scientific or clinical background desirable) and 8+ years experience in Regulatory Affairs in the pharmaceutical or biotechnology industry required.
Must have experience with managing NDA and MAA (eCTD) submissions, including submission writing and review experience. Experience with inhalation products would be a plus.
Must have experience of direct interaction with Regulatory Agencies.
Strong interpersonal and written/verbal communication skills.
Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter.
Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired.
Minimal travel may be required.
The following personal characteristics:
A bias towards action combined with high ethical standards.
A self-starter combined with a high energy level.
A bachelor?s degree in a relevant discipline is required. Advanced degree is preferred.
||Monmouth Junction, NJ |
THIS JOB HAS EXPIRED