Regulatory Submission Specialist II -WYETH-USA- Collegeville, PA
With limited supervision, coordinates the preparation and submission of various regulatory documents to health authorities. Working with input from supervisor, assures the quality and completeness of internal documents received for participates on regulatory teams for assigned projects/products.
Functional Summary - Produces high-quality submissions collaborating across GRA and other contributing departments, utilizing technology and improving internal processes, and improving navigation strategies within documents and across dossiers. GRSM is organized into three groups: Therapeutic Area Teams, Life-Cycle Management Team, and Submission Ready Component (SRC) Team. Some of the key activities include Dossier and Submission Publishing, including tracking of components, monitoring due dates and identification and follow-up on issues; solely responsible for Safety Report, New Investigator and Advertising and Promotional submissions; liaison with GRA and contributing groups for the appropriate use of eCTD functionality, including Attribute information, Operators, Repeatable nodes; Submission Ready Component Tools, Policies, Guidances, Customer Support, and coordination of the Submission Liaison Team.