Regulatory Submission Associate

Compile and publish assigned regulatory submissions.  Coordinate printing and distribution of those submissions to all concerned markets within agreed timeframes.  Manage the associated submission and product life-cycle information.
Responsibilities:
•  Effectively communicate submission format requirements to the submission team.
•  Collect necessary information and requirements from the submission team.
•  Contribute to the compilation and publishing of regulatory submissions in accordance with current standards and processes using agreed upon tools.
•  Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required.
•  With supervision, analyze submissions, track and record life-cycle information in accordance with standards.
•  Perform simple searches on submission life-cycle information, as required.
•  Take responsibility for and ensure regulatory submissions are navigable to comply with clients submission-ready standards.
•  Participate on project teams (e.g., skill work, standards, or harmonization).
•  Participate on SMG working teams.
•  Seek advice in and share best practices within SMG
•  The Job Holder has a responsibility to comply with, or be aware of (as appropriate)

Category:	Biotech/Pharmaceutical
Location:	Wilmington, DE
County:	New Castle County
ZIP Code:	19801
Pay Rate:	Negotiable
Job Terms:	4-6 months (contract)
Company:	PSCI
Phone:	1302-334-4107
Fax:	email only