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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)
Min 6 yrs required
Senior Director – Science and Regulatory Advocacy The candidate will report to the Deputy Vice President, Science and Regulatory Advocacy and work with colleagues across the organization to develop, evaluate and execute biosimilars and BsUFA advocacy priorities in the US and select international priority markets. Leading the development of firm policy and regulatory advocacy positions on biosimilars and BsUFA in close coordination with relevant firm departments and member companies. Executing and supporting on strategic projects and initiatives for biosimilars and BsUFA advocacy. Activities to include performing background research, creating project plans, managing deliverables, soliciting member company input, as well as actively guiding cross-functional discussions within firm and with firm member companies, external stakeholders, and US and international science and regulatory bodies. Developing and presenting project proposals and outputs to (SRA) leadership and working groups. Serving as a credible and compelling subject matter expert both internally and externally for all biosimilars-related regulatory policy issues. Actively managing SRA activities including the facilitation of teamwork within the department and firm-wide. Developing, presenting, and implementing budget lines for projects as well as managing various third-party contractors. Bachelor’s degree is required. Should have 4+ years of relevant experience in R&D, drug development or regulatory advocacy, or related disciplines. Must have 6+ years’ related work experience. Should have 3+ years of relevant experience recommending strategies and policy in biosimilars (strongly preferred) and advocacy experience. Must have knowledge of drug discovery, development and related FDA regulations. Experience advocating publicly on behalf of high-profile organizations is required. PhD, J.D. or other advanced degree is preferred. Experience with US and/or international biosimilars legal and regulatory frameworks is preferred. Experience with biologic products, including cell and gene therapy is preferred.
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