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Corporate Counsel, Regulatory Law
Refer job# SEKG136060
Corporate Counsel, Regulatory Law Duties: Responsibility for the interpretation and implementation of key FDA-related legislation, regulations and policies. 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. 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 Essential Health business on matters relating to the review and approval of sterile injectable products and complex generic products. Counseling 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.

Qualifications: Bachelor's Degree and JD Degree. Member of a state Bar/admitted to a relevant jurisdictions. 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 . Self-motivated and able to handle multiple demands and priorities simultaneously. Proven ability to proactively identify and analyze potential legal issues and develop creative and business focused legal advice and solutions. Proven ability to cultivate strong client relationships and successfully influence leadership in a fast paced, innovative business environment. Excellent communication and writing skills. Flexibility to travel as needed. Last Date to Apply for Job: 10/17/17
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