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Food & Drug Administration Attorney in Gaithersburg, MD

Emergent BioSolutions Inc. Sep 19,2017 Mar 31,2017 Location USA Gaithersburg MD
This job is expired...

In-House

Attorney

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

Min 5 yrs required

Profile

Sr Regulatory Counsel The candidate should be an experienced attorney focused in the area of pharmaceutical, biologic, and medical device FDA regulatory and compliance issues. Provide strategic advice and leadership in the areas governing product labeling, promotion, and distribution issues. Work closely with Regulatory, Clinical and Medical Affairs, Marketing, and Commercial Operations, others within the Legal Department and senior management and lead or assist, in all areas of the company’s regulatory compliance, including review of promotional materials, product labeling and regulatory submissions, distribution plans and strategies, and related commercial distribution and sales contracts. Lead or assist in regulatory matters involving cross-border transactions and sales, including in the drafting, negotiation, and closing of sales transactions. Advise on and assist in the review of promotional materials, product labeling, and regulatory submissions. Lead and assist, with a focus on regulatory compliance, on the company’s product marketing plans and strategies. Lead and assist in the drafting, negotiation, and closing of dealer and distribution agreements, for product sales in the U.S. and Internationally. Provide strategic legal advice on the regulatory pathway for obtaining marketing approvals of pharmaceutical, biologic and medical device products. Lead and assist in the drafting and negotiation of other contracts, such as research agreements, license agreements, clinical trial agreements, and manufacturing agreements. Provide legal advice on operational contracts as required and in particular on those related to areas of responsibility. J.D. and bar membership and 5+ years of relevant legal experience required. Substantial: legal experience with a FDA regulatory focus; legal experience with advertising and promotion laws in the US and internationally required. Biopharmaceutical industry experience desired, whether through in-house experience or law firm client base required. Experience: with International sales and cross-border transactions; with contract drafting and negotiation desired. Strong presentation skills to senior management required. Substantial legal knowledge and experience in primary disciplines and strong negotiating skills required.

Additional info

Job ID: 17661

Company info