Regulatory Integration Coordinator Job in West Point 19486, Pennsylvania Us
Qualifications:
- BA/BS in science related field. Regulatory experience preferred.
Responsibilities:
- Preparation/assembly of any or all Regulatory Submissions which are a direct result of the Merger. (This excludes any and all new product filings, line extensions, etc.)
- Ordering/Generating/Coordinating documents required (declarations, CPP's, etc) to support the filings
- Maintaining an up-to-date tracking list for all documents requested
- Creating and maintaining authoritative sources of requirements, contact lists, etc., as required
- Tracking/Updating filing status for product approval process in Teamsite spreadsheets
- Data entry into Level 1 /2 of End to End Regulatory Design Tool
- Training on Databases needed to perform these activities
- Correspondence with others working on these same activities
- Artwork/Labeling updates that are a result of the above submissions and working with the Artwork centers to get that artwork and labeling updated.
- Providing input into Supply Chain Plans resulting from merger-related activities
- Entering data into IT systems for review, update, approval at the local level (I.e. Orion/Great systems)
- Attending relevant meetings, taking and issuing minutes as needed, etc.
October 8, 2011
• Tags: Pennsylvania Us, Regulatory Integration Coordinator Job in West Point 19486 • Posted in: General