Senior Regulatory Counsel
5 days ago
About the Role
We are seeking an experienced Senior Regulatory Counsel to join our team as a strategic biopharmaceutical expert. As a subject matter expert on regulations and laws impacting research and global development within the biopharmaceutical industry, you will provide 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.
About You
With 10+ years of combined experience, preferably including work experience at FDA CBER/CDER and in-house experience in the biopharmaceutical industry, you possess a 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.
You have demonstrated experience as a valued business and regulatory lawyer and genuine team player, dynamic and resilient individual with the ability to make decisions and influence senior leaders, persuade, and build consensus across the organization and mentor and develop others.
Key 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.
Requirements
- Ten or more years combined experience.
- 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.
- 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.
- Excellent written and oral communication skills.
- Juris Doctor degree from an accredited law school; admitted to a US state bar in good standing.
Salary and Benefits
The salary for this role is $236,000-$354,000 per annum, depending on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. In addition to competitive base pay, we offer a range of benefits, including medical, dental, and vision insurance, a 401(k) retirement savings plan, flexible paid vacation, and eligibility for discretionary annual cash bonuses or incentive compensation and equity grants in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, and Long Term Equity Incentive Plan.
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