Regulatory Affairs - INTERN_Forest Laboratory_Jersey City, NJ

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http://www.frx.com/careers/job_description.aspx?number=97744

Regulatory Affairs - INTERN
Regulatory Affairs
Jersey City, NJ
Summary
Individuals in this role assist with regulatory compliance (i.e. "CFR
Required" activities) with respect to IND and NDA applications are met
in accordance with FDA guidelines and timelines

Duties and Responsibilities
¿Work closely with strategic regulatory affairs managers on all FDA
submissions

¿Assist coordinating IND and NDA submissions to FDA, including new
protocols, protocol amendments, Annual Reports, IND Safety Reports,
New INDs, Briefing Books, SPAs, etc.
oPrepare draft and finalize routine cover letters and FDA Forms
(1571/356h/3674)
oTrack components of submissions among author, DFS, RP, RA, & RO
oFinal Review and QA of paper and electronic submissions for format
oDistribute submissions to team in timely manner

¿Review and approve investigational drug shipments to study sites as
well as investigational drug labels

¿Assist in retrieval of submissions from Regulatory archives (upon
request of strategic regulatory manager, project team members, and/or
senior management)

¿Serve as liaison between strategic regulatory affairs and various
other departments within FRI, including Regulatory Operations (RO),
Regulatory Publishing (RP), Clinical, Clinical Pharmacology and Drug
Dynamics (CPDD), Clinical Supplies, Drug Safety, Documents Formats and
Standards (DFS). etc.
¿Coordinate submissions in Canada/EU/Latin America with Agent/CRO
¿Maintain submission documents in document management system (i.e.
RASS)
oMaintain version controls (especially in unpublished submissions)
¿Manage FDA letter templates
Requirements
Education: Completed or pursuing a 4-year degree in scientific
discipline.

Experience: Minimal to no experience required. This is an entry level
positon

Knowledge, Skills, and Abilities: Microsoft Applications (Word, Excel,
PowerPoint)



Posting Date: 09.23.09