Regulatory Affairs Specialist III - (Cambridge, MA)

Long term W2 Contract Opportunity for Regulatory Affairs Specialist III located in Cambridge, MA. Duties: This individual will support the US Labeling Head in drafting the scientific and regulatory content of new and revised labeling documents for Company products, for providing responses to Health Authorities requests related to labeling, and to perform other regulatory functions ensuring compliance of labeling documents with regulations and guidelines. This individual will support the preparation of US/International labeling (prescribing info and patient info) documents for marketed products to obtain health authority approval. Labeling for these products is based on study results, labeling review, preparation of labeling components for submission to regulatory agencies. A good knowledge of FDA regulations to ensure that accurate and full details is included on all labeling components - package inserts and packaging is a must.