The Position

The successful candidate will provide legal support and counseling to business clients on a wide range of FDA regulatory and compliance issues (including GxP compliance) for the commercial, research & development, and manufacturing organizations.

Responsibilities

Partnering with various stakeholders to perform risk assessments on proposed concepts and provide practical, solutions-oriented advice that meets business objectives while minimizing regulatory risk for the organization.

Providing regulatory interpretations, defending regulatory enforcement actions, and acting as liaison with outside counsel, where appropriate.

Providing legal support to the commercial organization as a member of the Promotion Review Committee.

Providing day-to-day legal advice to the labeling, quality, supply chain, and regulatory organizations in R&D and Manufacturing.

Preparing business clients for regulatory inspections.

Providing legal support for and review of regulatory submissions.

Providing legal advice on issues affecting clinical assets and marketed products.

Providing regulatory legal guidance on a range of additional issues including state licensing