Regulatory Counsel
International Biotechnology Leader
Locations : REMOTE
Alternative Option: (company will relocate you to the San Francisco area if you choose)
We are representing a high growth International Biotechnology Leader that is experiencing 80% 4-year cumulative revenue growth and 50% 4-year cumulative employee growth. The Regulatory Counsel role is new and is a function of our company growth.
Why Join Us? What we offer:
• 20-year history of success
• Accelerated revenue and employee growth based on robust pipeline and acquisitions
• Our latest acquisition was completed December 2021
• Be part of a legal team that is growing and providing career growth options
• Entrepreneurial environment that supports your creativity and imagination
Responsibilities of Regulatory Counsel:
• Provide quality and regulatory legal support for our California based laboratory services and product business, with an emphasis on US laws and regulations
• Provide clinical study legal support, particularly transactional legal support for all clinical study agreements
• Provide quality, regulatory and licensure support for our pharmacy business
• Provide regulatory assessment and support for our digital diagnostic application and platform business
• Provide general fraud, abuse, and anticorruption legal support for our compliance team
Qualifications of Regulatory Counsel:
• Juris Doctorate with an active state bar license
• Regulatory Counsel experience obtained in laboratory, pharmaceutical, biotech, healthcare or law firm setting
• Knowledge of issues pertaining to fraud and abuse, Stark Law, Anti-Kickback Statute, and False Claims
• Knowledge of Medicare and Medicaid reimbursement and billing rules
• Prefer knowledge of laws, regulations, and industry best practices for clinical diagnostic laboratories, clinical testing service and product providers
• Nice to have some knowledge of digital healthcare application and pharmacy licensing laws
Application Process for Regulatory Counsel:
• Please send your CV and compensation expectations to: maurice@conselium.com
• Please identify if you wish to work REMOTE or relocate to San Francisco area
