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Corporate Counsel, Regulatory Law
Refer job# XBSM136305
 
Corporate Counsel, Regulatory Law The candidate reports into the U.S. Regulatory Law team, with responsibility for the interpretation and implementation of key FDA-related legislation, regulations and policies. Responsibilities include counseling the business regarding the Hatch-Waxman Act and associated regulatory exclusivities, product lifecycle planning, post-marketing regulatory commitments, the generic drug review and approval process, regulatory requirements associated with product labeling/packaging/sampling, and partnering with our Regulatory and Legislative Affairs colleagues to advance initiatives important to company. Specific responsibilities include: Counseling regarding the interpretation and implementation of key FDA-related legislation, regulations and guidances, with a focus on matters involving regulatory exclusivities, product lifecycle planning, post-marketing regulatory commitments, DEA/controlled substance regulations, and drug review and approvals. Counseling company s Essential Health business on matters relating to the review and approval of sterile injectable products and complex generic products. Counseling company s U.S. Trade organization regarding applicable federal and state laws and regulations, including drug supply chain security legislation, import/export matters, and drug sampling matters. Counseling regarding FDA s regulation of manufacturer communications and evolving communication platforms including social media and mobile medical applications.

The candidate should have Bachelors degree and Juris Doctorate. Must be member of a state bar/admitted to a relevant jurisdictions. Must have 5-7 years of experience working in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including matters involving counseling on the interpretation of FDA-related legislation and regulations. Should have proven ability to proactively identify and analyze potential legal issues and develop creative and business focused legal advice and solutions. Must have excellent communication and writing skills.
 
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