Note you must apply at www.ebsi.com/careers citing Job Reference 17661
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
About this Role
The Senior Regulatory Counsel is an experienced attorney focused in the area of pharmaceutical, biologic, and medical device FDA regulatory and compliance issues. The Senior Regulatory Counsel will provide strategic advice and leadership in the areas governing product labeling, promotion, and distribution issues.
The Senior Regulatory Counsel will 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. The Senior Regulatory Counsel will also 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.