Senior Regulatory Counsel (Remote)

Based in the IP & Access to Medications team, the Senior Regulatory Counsel serves as a subject matter expert on regulations and laws impacting research and global development within the biopharmaceutical industry. The Senior Regulatory Counsel provides strategic guidance on pipeline development, FDA designations and exclusivity, expedited development pathways, marketing submissions, interactions with health authorities, post marketing obligations, international standards and harmonization efforts for multinational regulatory strategies, etc. The role reports to Vice President, Senior Associate General Counsel, Intellectual Property & Access to Medications Team, Legal and resides within the Regulatory Law & Strategy Center of Excellence.

Essential Functions/Responsibilities

• Proactively identify and provide strategic regulatory legal guidance for highly complex/non-standard US/regional/global programs, particularly in the oncology and neurology therapeutic areas.
• Provide expert regulatory legal advice to cross-functional teams engaged in collaborative research and development activities, including Global Regulatory Affairs & Drug Safety (GRADS), R&D, and Global Product Commercialization Teams.
• Work closely with colleagues in the Intellectual Property and Access to Medicines team, as well as colleagues throughout Legal, to develop comprehensive legal strategies to optimize the development programs of Jazz’s differentiated products and pipeline.
• Collaborate with Legal, Corporate and Government Affairs (LCG) colleagues and cross-functional teams to ensure appropriate expertise is applied to specialized issues, including regulatory strategy, product development & product approvals; promotion; post-approval compliance; FDA enforcement actions & litigation; due diligence reviews & transactional support.
• Keep abreast of changes in laws and regulations that may impact the regulation of Jazz product offerings and identify opportunities to influence and share learnings with internal stakeholders and colleagues.
• Identify policy development opportunities and collaborate with Government Affairs and Public Policy Team on outreach and external stakeholder engagement strategies.
• Help select and direct the work of outside counsel, define project objectives, and manage projects to ensure the work, strategy, and costs meet Jazz’s needs and expectations.
• Conduct regulatory due diligence in connection with potential M&A or other business transactions as needed.
• Partner with LCG colleagues in executing and enhancing corporate and department objectives.

Required Knowledge, Skills, and Abilities

• Ten or more years combined experience. Work experience at FDA CBER/CDER is highly preferred; in house experience in the biopharmaceutical industry a plus. Preferably, the candidate should have experience counseling biopharma companies in all stages of development with experience in the oncology area.
• Current and thorough knowledge of the Food, Drug & Cosmetic Act, associated regulations, FDA Guidance, and regulatory practices of the U.S. Food and Drug Administration in the regulation of small molecules, biologics and companion diagnostics.
• Experience with setting global strategies and working knowledge of global (ex-US) health authorities, such as EMA, Health Canada, PMDA, and their associated regional/country regulations highly desirable.
• Demonstrated experience as a valued business and regulatory lawyer and genuine team player.
• Dynamic and resilient individual with the demonstrated ability and confidence to make decisions and influence senior leaders, persuade, and build consensus across the organization and to mentor and develop others.
• Demonstrated ability to prioritize workload, meet deadlines and work with minimal supervision in a team and matrix environment, sound judgment and strong attention to detail.
• Excellent written and oral communication skills.

Required/Preferred Education and Licenses

• Juris Doctor degree from an accredited law school; admitted to a US state bar in good standing.
• Scientific or technical degree not required, but desirable.