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Senior Director – Law
2 months ago
PhRMA is seeking a highly skilled Senior Director to join our Law Department. As a key member of our team, you will provide regulatory counsel and advocacy support on issues related to the regulation and approval of biopharmaceutical products.
Key Responsibilities:- Serve as legal counsel for issues related to FDA regulation and approval of biopharmaceutical products.
- Advocate on behalf of PhRMA and its members on legal and regulatory issues with the US Food and Drug Administration (FDA), Congress, and other government agencies.
- Provide primary legal support for PhRMA's advocacy on manufacturing and quality-related issues, including GMPs, inspection-related issues, and supply chain considerations.
- Coordinate with external counsel and provide legal counsel to PhRMA's Scientific and Regulatory Advocacy Department.
- Perform other duties as assigned.
- JD and member of the DC Bar with at least 3+ years of experience in a law firm, as counsel in a biopharmaceutical company, or trade association.
- Experience with FDA regulatory law, including manufacturing, quality, and supply chain requirements.
- Exceptional written and verbal communication skills.
- Ability to manage multiple complex high-visibility priorities.
- Strong negotiating skills.
PhRMA represents the country's leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives.