California Licensed Senior Counsel II

Job Summary

To support a growing legal team, the remote full-time California Licensed Senior Counsel II will serve as a primary contact for development and regulatory matters, advising on complex business issues and collaborating with various departments throughout the product lifecycle.

Key responsibilities

• Providing legal guidance to global Development functions, including Clinical Development and Regulatory Affairs
• Advising on GXP requirements, adverse-event reporting, and regulatory submissions while managing supply chain legal issues
• Drafting and reviewing agreements and corporate policies, ensuring compliance with evolving regulatory requirements

Required qualifications

• U.S. Juris Doctorate (J.D.) degree with an active law license in at least one U.S. jurisdiction
• 6+ years of legal experience in the pharmaceutical industry, preferably with multinational companies or reputable law firms
• Strong knowledge of U.S. pharmaceutical regulatory laws and industry practices
• Experience advising on FDA and regulatory matters
• Ability to manage complex legal issues and provide practical solutions in a fast-paced environment