Description:
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 and environmental, health, and safety issues in the US.
- The successful candidate will also provide subject matter support to business development opportunities, quality investigations, pharmacovigilance agreements, supply agreements, quality agreements, and issues involving trade compliance.
Required Education, Experience and Skills
- A Bachelor's degree from an accredited institution.
- Graduate of an accredited US law school, with admission to the Bar of Pennsylvania, New Jersey, or another state.
- At least five (5) or more years of legal experience in a law firm or corporate setting.
- Excellent teamwork, communication (written and oral) and analytical skills, and a high degree of business acumen.
- Experience in managing a significant workload, with the ability to juggle competing tasks in a fast paced and challenging environment.
- Experience operating in ambiguous circumstances.
- Ability to provide timely, practical, and compliant solutions while managing legal risks and demonstrating superior legal judgment.
- Ability to be proactive and take initiative.
- Prior experience with pharmaceutical products required.
Preferred Experience and Skills:
- Experience with combination products and medical devices preferred.
- Prior GxP and FDA regulatory experience preferred.
