Senior Director Labelling-Pharmaceutical-New Jersey
Job Summary:
Prepare corporate, US and EU labeling documents for developmental, Life Cycle Management and marketed products to obtain company and/or agency approval. Development or updates of labeling for these products is based on study results, literature or other information relevant to the product or product class; coordination of labeling review and approval throughout the company; preparation of labeling components for submission to regulatory agencies; participation in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company; review of local labeling and participation with affiliates in agency replies for local issues and to assure compliance with corporate labeling.
Requirements:
- Master’s degree in scientific or medically-related field.
- Minimum of five years experience in the pharmaceutical industry, including regulatory experience and 13 or more years in work experience.
- Experience in Labeling Strategy Required.
- Detailed knowledge of US, EU and other local regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; knowledge of labeling requirements in all regions.
Send resume to summer @ pn-rn.com
1-855-582-5500
www .pn-rn.com
